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WATCHMAN left atrial appendage closure device

A device used to seal the left atrial appendage (a pouch off the upper left chamber of the heart) so that clots cannot form there and cause a stroke. In the PROTECT AF trial it was placed by percutaneous closure. The US Food and Drug Administration approved it in March 2015 for people with non-valvular atrial fibrillation who are at higher risk of stroke, are recommended for blood thinners, are suitable for warfarin, and have a reason to look for a non-drug alternative. In the PROTECT AF trial the device did not do worse than warfarin for the main outcome, and it had more serious safety events, mostly linked to the procedure.

Also called WATCHMAN

  • Product
  • In this atlas

Overview

Technical summary

FDA premarket approval P130013, decided 2015-03-13 (received 2013-05-14), applicant Boston Scientific Corp, product code NGV, device class 3, expedited review. The openFDA record holds the original approval and many later supplements, including newer device versions; this page covers the original approval and the PROTECT AF evidence on the first device version. The openFDA registration and listing records name Boston Scientific Corporation as a manufacturing establishment for the P130013 devices; that listing is current and does not show who made the first device in 2015.

Product details

Type
Device
Model or formulation
WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (as the PMA record names it)
Version
Original approval P130013; later supplements cover other versions and are not described here

Intended-use sources

No intended-use source is recorded.

Claims and evidence

Context Adults with non-valvular atrial fibrillation who were eligible for long-term warfarin (PROTECT AF)

Recipient
Adult
Population
Adults with paroxysmal, persistent or permanent non-valvular atrial fibrillation who were eligible for long-term warfarin and had at least one of: previous stroke or transient ischemic attack, congestive heart failure, diabetes, hypertension, or age 75 or older (abstract wording; the registry gives a CHADS score of 1 or more).
Care setting
Not stated in the abstract or the registry record
Geography
Registry sites in the United States, Czechia and Germany
Life stage
Adults aged 18 or older (registry minimum age)
Follow-up
The abstract gives 1065 patient-years of follow-up. The registry lists the primary completion as 2013-08.
Eligibility: 3 inclusion criteria; 4 exclusion criteria
Included
  • Non-valvular atrial fibrillation (paroxysmal, persistent or permanent)
  • Eligible for long-term warfarin
  • At least one of: previous stroke or transient ischemic attack, congestive heart failure, diabetes, hypertension, or age 75 or older (abstract wording)
Excluded
  • Contraindicated for warfarin
  • Contraindicated for aspirin or clopidogrel
  • Implanted mechanical valve
  • Other exclusions are listed in the registry

  • Effect Interventional Certainty not assessed

    In PROTECT AF, a multicentre, randomised non-inferiority trial, 707 eligible adults with non-valvular atrial fibrillation were randomly assigned 2:1 to percutaneous closure of the left atrial appendage with the WATCHMAN device and subsequent discontinuation of warfarin (463 patients) or to warfarin with a target international normalised ratio of 2.0 to 3.0 (244 patients). Analysis was by intention to treat. At 1065 patient-years of follow-up, the primary efficacy event rate (a composite of stroke, cardiovascular death and systemic embolism) was 3.0 per 100 patient-years (95% credible interval 1.9 to 4.5) in the device group and 4.9 per 100 patient-years (2.8 to 7.1) in the warfarin group (rate ratio 0.62, 95% credible interval 0.35 to 1.25, which includes 1). The probability of non-inferiority was more than 99.9%. Primary safety events (major bleeding, pericardial effusion and device embolisation) were more frequent in the device group, 7.4 per 100 patient-years (95% credible interval 5.5 to 9.7), than in the control group, 4.4 per 100 patient-years (2.5 to 6.7) (rate ratio 1.69, 1.01 to 3.19). The authors write that the safety events in the device group were mainly a result of periprocedural complications.

    Source problem. A cited source is corrected. Check the sources before relying on this claim.

    Applies to Adult
    • Adults with paroxysmal, persistent or permanent non-valvular atrial fibrillation who were eligible for long-term warfarin and had at least one of: previous stroke or transient ischemic attack, congestive heart failure, diabetes, hypertension, or age 75 or older (abstract wording; the registry gives a CHADS score of 1 or more).
    • Not stated in the abstract or the registry record
    • Registry sites in the United States, Czechia and Germany
    • Adults aged 18 or older (registry minimum age)
    Follow-up The abstract gives 1065 patient-years of follow-up. The registry lists the primary completion as 2013-08.
    Certainty method
    Not assessed
    Limitations
    Abstract of the 2009 report only; the full text was not read. The result is for the first device in the trial, not for later WATCHMAN versions. The intervals are Bayesian 95% credible intervals, and the trial tested non-inferiority with a two-fold margin. The interval for the efficacy rate ratio (0.35 to 1.25) includes 1, so the trial does not show that the device was better than warfarin. Primary safety events were higher with the device (rate ratio 1.69). The trial enrolled people who were eligible for warfarin, so it does not test the device in people who cannot take blood thinners. The abstract names Atritech as funder, while the registry lists Boston Scientific Corporation as lead sponsor; the sources do not explain the difference. PubMed links a published erratum (Lancet 2009 Nov 7;374(9701):1596) and Crossref lists an erratum notice (doi 10.1016/S0140-6736(09)61953-X); neither was read, so the numbers may not match the corrected paper. The registry enrollment (800) includes non-randomized roll-in participants that the abstract does not count among the 707 randomized.
    Last checked
    2026-10-14
    Next evidence check due
    Not scheduled
    Sources and citations (22)

    1. Supports Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial

      Publication · Journal record via PubMed (Lancet 2009;374(9689):534-42) · Edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (Lancet 2009 Nov 7;374(9701):1596) that was not read, so the source state is corrected. · Published 2009-08-15 · DOI: 10.1016/S0140-6736(09)61343-X · PMID: 19683639

      Locator
      Abstract, METHODS, sentence 1, fragment 1
      How it applies
      Population (first fragment).
      Retrieved
      Source effective date
      Not reported
      Source state
      Corrected
      Snapshot hash
      ae1a4b92d513fd39f7641f7d3ba1064aecb46f6b32da09ea485e00c023c87b77
      Reuse basis
      PubMed record fetched through NCBI E-utilities (label cf-pubmed-19683639.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    2. Supports Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial

      Publication · Journal record via PubMed (Lancet 2009;374(9689):534-42) · Edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (Lancet 2009 Nov 7;374(9701):1596) that was not read, so the source state is corrected. · Published 2009-08-15 · DOI: 10.1016/S0140-6736(09)61343-X · PMID: 19683639

      Locator
      Abstract, METHODS, sentence 1, fragment 2
      How it applies
      Eligibility risk factors (second fragment).
      Retrieved
      Source effective date
      Not reported
      Source state
      Corrected
      Snapshot hash
      ae1a4b92d513fd39f7641f7d3ba1064aecb46f6b32da09ea485e00c023c87b77
      Reuse basis
      PubMed record fetched through NCBI E-utilities (label cf-pubmed-19683639.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    3. Supports Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial

      Publication · Journal record via PubMed (Lancet 2009;374(9689):534-42) · Edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (Lancet 2009 Nov 7;374(9701):1596) that was not read, so the source state is corrected. · Published 2009-08-15 · DOI: 10.1016/S0140-6736(09)61343-X · PMID: 19683639

      Locator
      Abstract, METHODS, sentence 1, fragment 3
      How it applies
      Eligibility age (third fragment).
      Retrieved
      Source effective date
      Not reported
      Source state
      Corrected
      Snapshot hash
      ae1a4b92d513fd39f7641f7d3ba1064aecb46f6b32da09ea485e00c023c87b77
      Reuse basis
      PubMed record fetched through NCBI E-utilities (label cf-pubmed-19683639.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    4. Supports Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial

      Publication · Journal record via PubMed (Lancet 2009;374(9689):534-42) · Edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (Lancet 2009 Nov 7;374(9701):1596) that was not read, so the source state is corrected. · Published 2009-08-15 · DOI: 10.1016/S0140-6736(09)61343-X · PMID: 19683639

      Locator
      Abstract, METHODS, sentence 2, fragment 1
      How it applies
      Randomization and intervention arm (first fragment).
      Retrieved
      Source effective date
      Not reported
      Source state
      Corrected
      Snapshot hash
      ae1a4b92d513fd39f7641f7d3ba1064aecb46f6b32da09ea485e00c023c87b77
      Reuse basis
      PubMed record fetched through NCBI E-utilities (label cf-pubmed-19683639.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    5. Supports Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial

      Publication · Journal record via PubMed (Lancet 2009;374(9689):534-42) · Edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (Lancet 2009 Nov 7;374(9701):1596) that was not read, so the source state is corrected. · Published 2009-08-15 · DOI: 10.1016/S0140-6736(09)61343-X · PMID: 19683639

      Locator
      Abstract, METHODS, sentence 2, fragment 2
      How it applies
      Control arm (second fragment).
      Retrieved
      Source effective date
      Not reported
      Source state
      Corrected
      Snapshot hash
      ae1a4b92d513fd39f7641f7d3ba1064aecb46f6b32da09ea485e00c023c87b77
      Reuse basis
      PubMed record fetched through NCBI E-utilities (label cf-pubmed-19683639.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    6. Supports Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial

      Publication · Journal record via PubMed (Lancet 2009;374(9689):534-42) · Edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (Lancet 2009 Nov 7;374(9701):1596) that was not read, so the source state is corrected. · Published 2009-08-15 · DOI: 10.1016/S0140-6736(09)61343-X · PMID: 19683639

      Locator
      Abstract, METHODS, sentence 3
      How it applies
      Primary efficacy composite.
      Retrieved
      Source effective date
      Not reported
      Source state
      Corrected
      Snapshot hash
      ae1a4b92d513fd39f7641f7d3ba1064aecb46f6b32da09ea485e00c023c87b77
      Reuse basis
      PubMed record fetched through NCBI E-utilities (label cf-pubmed-19683639.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    7. Supports Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial

      Publication · Journal record via PubMed (Lancet 2009;374(9689):534-42) · Edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (Lancet 2009 Nov 7;374(9701):1596) that was not read, so the source state is corrected. · Published 2009-08-15 · DOI: 10.1016/S0140-6736(09)61343-X · PMID: 19683639

      Locator
      Abstract, METHODS, sentence 4
      How it applies
      Non-inferiority criterion.
      Retrieved
      Source effective date
      Not reported
      Source state
      Corrected
      Snapshot hash
      ae1a4b92d513fd39f7641f7d3ba1064aecb46f6b32da09ea485e00c023c87b77
      Reuse basis
      PubMed record fetched through NCBI E-utilities (label cf-pubmed-19683639.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    8. Supports Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial

      Publication · Journal record via PubMed (Lancet 2009;374(9689):534-42) · Edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (Lancet 2009 Nov 7;374(9701):1596) that was not read, so the source state is corrected. · Published 2009-08-15 · DOI: 10.1016/S0140-6736(09)61343-X · PMID: 19683639

      Locator
      Abstract, METHODS, sentence 5
      How it applies
      Primary safety endpoint.
      Retrieved
      Source effective date
      Not reported
      Source state
      Corrected
      Snapshot hash
      ae1a4b92d513fd39f7641f7d3ba1064aecb46f6b32da09ea485e00c023c87b77
      Reuse basis
      PubMed record fetched through NCBI E-utilities (label cf-pubmed-19683639.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    9. Supports Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial

      Publication · Journal record via PubMed (Lancet 2009;374(9689):534-42) · Edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (Lancet 2009 Nov 7;374(9701):1596) that was not read, so the source state is corrected. · Published 2009-08-15 · DOI: 10.1016/S0140-6736(09)61343-X · PMID: 19683639

      Locator
      Abstract, METHODS, sentence 6
      How it applies
      Intention-to-treat analysis.
      Retrieved
      Source effective date
      Not reported
      Source state
      Corrected
      Snapshot hash
      ae1a4b92d513fd39f7641f7d3ba1064aecb46f6b32da09ea485e00c023c87b77
      Reuse basis
      PubMed record fetched through NCBI E-utilities (label cf-pubmed-19683639.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    10. Supports Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial

      Publication · Journal record via PubMed (Lancet 2009;374(9689):534-42) · Edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (Lancet 2009 Nov 7;374(9701):1596) that was not read, so the source state is corrected. · Published 2009-08-15 · DOI: 10.1016/S0140-6736(09)61343-X · PMID: 19683639

      Locator
      Abstract, FINDINGS, sentence 1, fragment 1
      How it applies
      Efficacy event rates (first fragment).
      Retrieved
      Source effective date
      Not reported
      Source state
      Corrected
      Snapshot hash
      ae1a4b92d513fd39f7641f7d3ba1064aecb46f6b32da09ea485e00c023c87b77
      Reuse basis
      PubMed record fetched through NCBI E-utilities (label cf-pubmed-19683639.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    11. Supports Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial

      Publication · Journal record via PubMed (Lancet 2009;374(9689):534-42) · Edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (Lancet 2009 Nov 7;374(9701):1596) that was not read, so the source state is corrected. · Published 2009-08-15 · DOI: 10.1016/S0140-6736(09)61343-X · PMID: 19683639

      Locator
      Abstract, FINDINGS, sentence 1, fragment 2
      How it applies
      Efficacy rate ratio (second fragment).
      Retrieved
      Source effective date
      Not reported
      Source state
      Corrected
      Snapshot hash
      ae1a4b92d513fd39f7641f7d3ba1064aecb46f6b32da09ea485e00c023c87b77
      Reuse basis
      PubMed record fetched through NCBI E-utilities (label cf-pubmed-19683639.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    12. Supports Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial

      Publication · Journal record via PubMed (Lancet 2009;374(9689):534-42) · Edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (Lancet 2009 Nov 7;374(9701):1596) that was not read, so the source state is corrected. · Published 2009-08-15 · DOI: 10.1016/S0140-6736(09)61343-X · PMID: 19683639

      Locator
      Abstract, FINDINGS, sentence 2
      How it applies
      Probability of non-inferiority.
      Retrieved
      Source effective date
      Not reported
      Source state
      Corrected
      Snapshot hash
      ae1a4b92d513fd39f7641f7d3ba1064aecb46f6b32da09ea485e00c023c87b77
      Reuse basis
      PubMed record fetched through NCBI E-utilities (label cf-pubmed-19683639.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    13. Supports Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial

      Publication · Journal record via PubMed (Lancet 2009;374(9689):534-42) · Edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (Lancet 2009 Nov 7;374(9701):1596) that was not read, so the source state is corrected. · Published 2009-08-15 · DOI: 10.1016/S0140-6736(09)61343-X · PMID: 19683639

      Locator
      Abstract, FINDINGS, sentence 3, fragment 1
      How it applies
      Primary safety events (first fragment).
      Retrieved
      Source effective date
      Not reported
      Source state
      Corrected
      Snapshot hash
      ae1a4b92d513fd39f7641f7d3ba1064aecb46f6b32da09ea485e00c023c87b77
      Reuse basis
      PubMed record fetched through NCBI E-utilities (label cf-pubmed-19683639.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    14. Supports Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial

      Publication · Journal record via PubMed (Lancet 2009;374(9689):534-42) · Edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (Lancet 2009 Nov 7;374(9701):1596) that was not read, so the source state is corrected. · Published 2009-08-15 · DOI: 10.1016/S0140-6736(09)61343-X · PMID: 19683639

      Locator
      Abstract, FINDINGS, sentence 3, fragment 2
      How it applies
      Primary safety events (second fragment).
      Retrieved
      Source effective date
      Not reported
      Source state
      Corrected
      Snapshot hash
      ae1a4b92d513fd39f7641f7d3ba1064aecb46f6b32da09ea485e00c023c87b77
      Reuse basis
      PubMed record fetched through NCBI E-utilities (label cf-pubmed-19683639.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    15. Background Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial

      Publication · Journal record via PubMed (Lancet 2009;374(9689):534-42) · Edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (Lancet 2009 Nov 7;374(9701):1596) that was not read, so the source state is corrected. · Published 2009-08-15 · DOI: 10.1016/S0140-6736(09)61343-X · PMID: 19683639

      Locator
      Abstract, INTERPRETATION, sentence 1
      How it applies
      The authors' interpretation: non-inferior efficacy.
      Retrieved
      Source effective date
      Not reported
      Source state
      Corrected
      Snapshot hash
      ae1a4b92d513fd39f7641f7d3ba1064aecb46f6b32da09ea485e00c023c87b77
      Reuse basis
      PubMed record fetched through NCBI E-utilities (label cf-pubmed-19683639.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    16. Background Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial

      Publication · Journal record via PubMed (Lancet 2009;374(9689):534-42) · Edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (Lancet 2009 Nov 7;374(9701):1596) that was not read, so the source state is corrected. · Published 2009-08-15 · DOI: 10.1016/S0140-6736(09)61343-X · PMID: 19683639

      Locator
      Abstract, INTERPRETATION, sentence 2, fragment 2
      How it applies
      The authors' reading of the safety events.
      Retrieved
      Source effective date
      Not reported
      Source state
      Corrected
      Snapshot hash
      ae1a4b92d513fd39f7641f7d3ba1064aecb46f6b32da09ea485e00c023c87b77
      Reuse basis
      PubMed record fetched through NCBI E-utilities (label cf-pubmed-19683639.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    17. Background Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial

      Publication · Journal record via PubMed (Lancet 2009;374(9689):534-42) · Edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (Lancet 2009 Nov 7;374(9701):1596) that was not read, so the source state is corrected. · Published 2009-08-15 · DOI: 10.1016/S0140-6736(09)61343-X · PMID: 19683639

      Locator
      Abstract, FUNDING
      How it applies
      Funder named in the abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Corrected
      Snapshot hash
      ae1a4b92d513fd39f7641f7d3ba1064aecb46f6b32da09ea485e00c023c87b77
      Reuse basis
      PubMed record fetched through NCBI E-utilities (label cf-pubmed-19683639.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    18. Background Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial

      Publication · Journal record via PubMed (Lancet 2009;374(9689):534-42) · Edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (Lancet 2009 Nov 7;374(9701):1596) that was not read, so the source state is corrected. · Published 2009-08-15 · DOI: 10.1016/S0140-6736(09)61343-X · PMID: 19683639

      Locator
      PubMed record, CommentsCorrections (ErratumIn)
      How it applies
      PubMed links a published erratum whose content was not read.
      Retrieved
      Source effective date
      Not reported
      Source state
      Corrected
      Snapshot hash
      ae1a4b92d513fd39f7641f7d3ba1064aecb46f6b32da09ea485e00c023c87b77
      Reuse basis
      PubMed record fetched through NCBI E-utilities (label cf-pubmed-19683639.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    19. Background Crossref record of the PROTECT AF paper (10.1016/S0140-6736(09)61343-X)

      Dataset · Crossref · Edition Crossref works response fetched 2026-10-14 as cf-crossref-S0140-6736-09-61343-X.json. It lists an erratum notice that updates the paper.

      Locator
      message.updated-by[0].DOI
      How it applies
      Crossref lists an erratum notice, DOI 10.1016/S0140-6736(09)61953-X, that updates the paper. Its text was not read.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      0d4ab84a37f884c038a1c3af9e6ed5c30bf5dde9687d005b61da74ea93d83831
      Reuse basis
      Crossref metadata terms were not read here, so only the hash is kept and public text is cite_only until the integration owner confirms them.

    20. Background WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation (PROTECT AF)

      Registry · U.S. National Library of Medicine (ClinicalTrials.gov) · Edition ClinicalTrials.gov API v2 record fetched 2026-10-14. Last update posted 2015-05-15. · NCT: NCT00129545

      Locator
      protocolSection.designModule.enrollmentInfo.count
      How it applies
      Registry enrollment count, which includes roll-in participants.
      Retrieved
      Source effective date
      2015-05-15
      Source state
      Current
      Snapshot hash
      a7a1a7fd66cd0be9999cb7ebe0ce22652b54b7ab1ba0f1c97b987b0455dc517f
      Reuse basis
      Registry record. The raw API JSON is committed at research/snapshots/cf-ctgov-NCT00129545.json. The ClinicalTrials.gov terms page is rendered by JavaScript and its text was not read, so the redistribution basis is unverified. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) that registries allow short quotations with attribution. Any quotation stays short.

    21. Background WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation (PROTECT AF)

      Registry · U.S. National Library of Medicine (ClinicalTrials.gov) · Edition ClinicalTrials.gov API v2 record fetched 2026-10-14. Last update posted 2015-05-15. · NCT: NCT00129545

      Locator
      protocolSection.sponsorCollaboratorsModule.leadSponsor.name
      How it applies
      Registry lead sponsor.
      Retrieved
      Source effective date
      2015-05-15
      Source state
      Current
      Snapshot hash
      a7a1a7fd66cd0be9999cb7ebe0ce22652b54b7ab1ba0f1c97b987b0455dc517f
      Reuse basis
      Registry record. The raw API JSON is committed at research/snapshots/cf-ctgov-NCT00129545.json. The ClinicalTrials.gov terms page is rendered by JavaScript and its text was not read, so the redistribution basis is unverified. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) that registries allow short quotations with attribution. Any quotation stays short.

    22. Background WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation (PROTECT AF)

      Registry · U.S. National Library of Medicine (ClinicalTrials.gov) · Edition ClinicalTrials.gov API v2 record fetched 2026-10-14. Last update posted 2015-05-15. · NCT: NCT00129545

      Locator
      protocolSection.armsInterventionsModule.armGroups[2].description
      How it applies
      Registry description of the roll-in group.
      Retrieved
      Source effective date
      2015-05-15
      Source state
      Current
      Snapshot hash
      a7a1a7fd66cd0be9999cb7ebe0ce22652b54b7ab1ba0f1c97b987b0455dc517f
      Reuse basis
      Registry record. The raw API JSON is committed at research/snapshots/cf-ctgov-NCT00129545.json. The ClinicalTrials.gov terms page is rendered by JavaScript and its text was not read, so the redistribution basis is unverified. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) that registries allow short quotations with attribution. Any quotation stays short.

Context United States premarket approval P130013 for the WATCHMAN left atrial appendage closure technology

Recipient
Recipient not specified
Population
People with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASC scores and are recommended for anticoagulation therapy, are deemed by their physicians to be suitable for warfarin, and have an appropriate rationale to seek a non-pharmacologic alternative to warfarin (the wording of the openFDA approval order statement).
Care setting
Not stated in the FDA record
Geography
United States (decision by the US Food and Drug Administration)
Life stage
Not stated in the FDA record (it says people with non-valvular atrial fibrillation and gives no age)
Gestational age
Not reported
Postnatal age
Not reported
Follow-up
Not applicable (regulatory decision)
Eligibility: 4 inclusion criteria; exclusion criteria not stated
Included
  • Non-valvular atrial fibrillation
  • At increased risk for stroke and systemic embolism by CHADS2 or CHA2DS2-VASC score and recommended for anticoagulation therapy
  • Deemed by their physicians to be suitable for warfarin
  • An appropriate rationale to seek a non-pharmacologic alternative to warfarin
Excluded
None stated

  • Regulatory Evidence stage not applicable Certainty not assessed

    The US Food and Drug Administration approved premarket approval application P130013 for the WATCHMAN left atrial appendage closure technology on 13 March 2015, after receiving it on 14 May 2013. The openFDA record names Boston Scientific Corp as applicant and gives product code NGV, device class 3 and an expedited review flag of Y. Its approval-order statement says the device is intended to lower the risk of thromboembolism from the left atrial appendage in people with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism by CHADS2 or CHA2DS2-VASC score and are recommended for anticoagulation therapy, who are deemed by their physicians to be suitable for warfarin, and who have an appropriate rationale to seek a non-pharmacologic alternative to warfarin, taking into account how safe and effective the device is compared with warfarin.

    Applies to Recipient not specified
    • People with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASC scores and are recommended for anticoagulation therapy, are deemed by their physicians to be suitable for warfarin, and have an appropriate rationale to seek a non-pharmacologic alternative to warfarin (the wording of the openFDA approval order statement).
    • Not stated in the FDA record
    • United States (decision by the US Food and Drug Administration)
    • Not stated in the FDA record (it says people with non-valvular atrial fibrillation and gives no age)
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up Not applicable (regulatory decision)
    Certainty method
    Not assessed
    Limitations
    This is the original approval; the openFDA data hold many later supplements to P130013, including newer device versions, which are not described here. The approval wording ties the device to people who are suitable for warfarin and have a rationale to seek an alternative. It is not a statement that the device is better than warfarin. PROTECT AF tested the first device version. openFDA data are unvalidated.
    Last checked
    2026-10-14
    Next evidence check due
    Not scheduled
    Sources and citations (15)

    1. Supports FDA premarket approval P130013: WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record for the original approval (decision date 2015-03-13), selected from the 85 records of P130013 (the original and its supplements) by its decision date. Dataset last updated 2026-10-05. · PMA: P130013

      Locator
      results[0].pma_number
      How it applies
      PMA number.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      fd4d014d0a13d8ac7714d7db917cc79df553608b883528496eb4221c12d22670
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cf-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/cf-openfda-pma-P130013-original.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

    2. Supports FDA premarket approval P130013: WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record for the original approval (decision date 2015-03-13), selected from the 85 records of P130013 (the original and its supplements) by its decision date. Dataset last updated 2026-10-05. · PMA: P130013

      Locator
      results[0].applicant
      How it applies
      The applicant.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      fd4d014d0a13d8ac7714d7db917cc79df553608b883528496eb4221c12d22670
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cf-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/cf-openfda-pma-P130013-original.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

    3. Supports FDA premarket approval P130013: WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record for the original approval (decision date 2015-03-13), selected from the 85 records of P130013 (the original and its supplements) by its decision date. Dataset last updated 2026-10-05. · PMA: P130013

      Locator
      results[0].trade_name
      How it applies
      Trade name of the device.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      fd4d014d0a13d8ac7714d7db917cc79df553608b883528496eb4221c12d22670
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cf-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/cf-openfda-pma-P130013-original.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

    4. Supports FDA premarket approval P130013: WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record for the original approval (decision date 2015-03-13), selected from the 85 records of P130013 (the original and its supplements) by its decision date. Dataset last updated 2026-10-05. · PMA: P130013

      Locator
      results[0].decision_date
      How it applies
      Decision date.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      fd4d014d0a13d8ac7714d7db917cc79df553608b883528496eb4221c12d22670
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cf-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/cf-openfda-pma-P130013-original.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

    5. Supports FDA premarket approval P130013: WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record for the original approval (decision date 2015-03-13), selected from the 85 records of P130013 (the original and its supplements) by its decision date. Dataset last updated 2026-10-05. · PMA: P130013

      Locator
      results[0].date_received
      How it applies
      Date FDA received the application.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      fd4d014d0a13d8ac7714d7db917cc79df553608b883528496eb4221c12d22670
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cf-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/cf-openfda-pma-P130013-original.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

    6. Supports FDA premarket approval P130013: WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record for the original approval (decision date 2015-03-13), selected from the 85 records of P130013 (the original and its supplements) by its decision date. Dataset last updated 2026-10-05. · PMA: P130013

      Locator
      results[0].decision_code
      How it applies
      Decision code APPR.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      fd4d014d0a13d8ac7714d7db917cc79df553608b883528496eb4221c12d22670
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cf-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/cf-openfda-pma-P130013-original.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

    7. Supports FDA premarket approval P130013: WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record for the original approval (decision date 2015-03-13), selected from the 85 records of P130013 (the original and its supplements) by its decision date. Dataset last updated 2026-10-05. · PMA: P130013

      Locator
      results[0].product_code
      How it applies
      Product code.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      fd4d014d0a13d8ac7714d7db917cc79df553608b883528496eb4221c12d22670
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cf-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/cf-openfda-pma-P130013-original.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

    8. Supports FDA premarket approval P130013: WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record for the original approval (decision date 2015-03-13), selected from the 85 records of P130013 (the original and its supplements) by its decision date. Dataset last updated 2026-10-05. · PMA: P130013

      Locator
      results[0].openfda.device_class
      How it applies
      Device class as the openFDA block writes it.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      fd4d014d0a13d8ac7714d7db917cc79df553608b883528496eb4221c12d22670
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cf-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/cf-openfda-pma-P130013-original.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

    9. Supports FDA premarket approval P130013: WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record for the original approval (decision date 2015-03-13), selected from the 85 records of P130013 (the original and its supplements) by its decision date. Dataset last updated 2026-10-05. · PMA: P130013

      Locator
      results[0].expedited_review_flag
      How it applies
      Expedited review flag.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      fd4d014d0a13d8ac7714d7db917cc79df553608b883528496eb4221c12d22670
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cf-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/cf-openfda-pma-P130013-original.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

    10. Supports FDA premarket approval P130013: WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record for the original approval (decision date 2015-03-13), selected from the 85 records of P130013 (the original and its supplements) by its decision date. Dataset last updated 2026-10-05. · PMA: P130013

      Locator
      results[0].ao_statement
      How it applies
      Approval-order statement, part 1.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      fd4d014d0a13d8ac7714d7db917cc79df553608b883528496eb4221c12d22670
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cf-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/cf-openfda-pma-P130013-original.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

    11. Supports FDA premarket approval P130013: WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record for the original approval (decision date 2015-03-13), selected from the 85 records of P130013 (the original and its supplements) by its decision date. Dataset last updated 2026-10-05. · PMA: P130013

      Locator
      results[0].ao_statement (passage 2)
      How it applies
      Approval-order statement, part 2.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      fd4d014d0a13d8ac7714d7db917cc79df553608b883528496eb4221c12d22670
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cf-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/cf-openfda-pma-P130013-original.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

    12. Supports FDA premarket approval P130013: WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record for the original approval (decision date 2015-03-13), selected from the 85 records of P130013 (the original and its supplements) by its decision date. Dataset last updated 2026-10-05. · PMA: P130013

      Locator
      results[0].ao_statement (passage 3)
      How it applies
      Approval-order statement, part 3.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      fd4d014d0a13d8ac7714d7db917cc79df553608b883528496eb4221c12d22670
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cf-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/cf-openfda-pma-P130013-original.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

    13. Supports FDA premarket approval P130013: WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record for the original approval (decision date 2015-03-13), selected from the 85 records of P130013 (the original and its supplements) by its decision date. Dataset last updated 2026-10-05. · PMA: P130013

      Locator
      results[0].ao_statement (passage 4)
      How it applies
      Approval-order statement, part 4.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      fd4d014d0a13d8ac7714d7db917cc79df553608b883528496eb4221c12d22670
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cf-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/cf-openfda-pma-P130013-original.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

    14. Supports FDA premarket approval P130013: WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record for the original approval (decision date 2015-03-13), selected from the 85 records of P130013 (the original and its supplements) by its decision date. Dataset last updated 2026-10-05. · PMA: P130013

      Locator
      results[0].ao_statement (passage 5)
      How it applies
      Approval-order statement, part 5.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      fd4d014d0a13d8ac7714d7db917cc79df553608b883528496eb4221c12d22670
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cf-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/cf-openfda-pma-P130013-original.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

    15. Background FDA premarket approval P130013: WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record for the original approval (decision date 2015-03-13), selected from the 85 records of P130013 (the original and its supplements) by its decision date. Dataset last updated 2026-10-05. · PMA: P130013

      Locator
      meta.disclaimer
      How it applies
      openFDA's own disclaimer about relying on its data.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      fd4d014d0a13d8ac7714d7db917cc79df553608b883528496eb4221c12d22670
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cf-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/cf-openfda-pma-P130013-original.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

Authorization

Regulatory decision: WATCHMAN left atrial appendage closure device

Applies to Recipient not specified
  • People with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASC scores and are recommended for anticoagulation therapy, are deemed by their physicians to be suitable for warfarin, and have an appropriate rationale to seek a non-pharmacologic alternative to warfarin (the wording of the openFDA approval order statement).
  • Not stated in the FDA record
  • United States (decision by the US Food and Drug Administration)
  • Not stated in the FDA record (it says people with non-valvular atrial fibrillation and gives no age)
  • Gestational age Not reported
  • Postnatal age Not reported
Follow-up Not applicable (regulatory decision)
Authority
U.S. Food and Drug Administration
Decision
Approval,
Pathway
PMA
Submission
P130013
Product code
NGV
Device class
Class III
Jurisdictions
United States; note: United States
Product version
Not stated in the FDA record (the original approval; later supplements cover newer versions)
Indication
To reduce the risk of thromboembolism from the left atrial appendage in people with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism, are recommended for anticoagulation therapy, are deemed suitable for warfarin and have an appropriate rationale to seek a non-pharmacologic alternative (openFDA approval-order statement, summarized)
Basis
The US Food and Drug Administration approved premarket approval application P130013 for the WATCHMAN left atrial appendage closure technology on 13 March 2015, after receiving it on 14 May 2013. The openFDA record names Boston Scientific Corp as applicant and gives product code NGV, device class 3 and an expedited review flag of Y. Its approval-order statement says the device is intended to lower the risk of thromboembolism from the left atrial appendage in people with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism by CHADS2 or CHA2DS2-VASC score and are recommended for anticoagulation therapy, who are deemed by their physicians to be suitable for warfarin, and who have an appropriate rationale to seek a non-pharmacologic alternative to warfarin, taking into account how safe and effective the device is compared with warfarin.

Limitations. This is the original approval; the openFDA data hold many later supplements to P130013, including newer device versions, which are not described here. The approval wording ties the device to people who are suitable for warfarin and have a rationale to seek an alternative. It is not a statement that the device is better than warfarin. PROTECT AF tested the first device version. openFDA data are unvalidated.

A regulatory decision is separate from a guideline recommendation and from payment coverage.

Clinical links

Each link reports what one cited claim says about one population. "Evaluated for" means studied, not shown to work. These links do not show that anything is effective or right for you.

Record details

Record id
cardio:watchman
Content hash
25fc861d91d8bcb02d31b3c5809932feff83a7224ef1f40c4332690373631ddd