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Amplatzer Septal Occluder

A device from Abbott that closes a hole between the two upper heart chambers (an atrial septal defect) through a catheter. NHLBI lists catheter repair and surgery as ways to close such a hole. The US FDA approved it in 2001 for atrial septal defects of the secundum type with echocardiographic evidence of the defect and clinical evidence of extra work for the right lower chamber (a left-to-right shunt of 1.5 to 1 or an enlarged right ventricle), and for closing the opening left after a fenestrated Fontan procedure. The FDA approval does not state an age range.

Also called Amplatzer ASO · ASO

  • Product
  • In this atlas

Overview

Technical summary

Amplatzer Septal Occluder (ASO) and Amplatzer Exchange System, FDA product code MLV, PMA P000039, approved 2001-12-05. The approval order lists secundum atrial septal defect closure for patients with echocardiographic evidence of an ostium secundum defect and clinical evidence of right ventricular volume overload, and closure of the fenestration in patients who had a fenestrated Fontan procedure. NHLBI lists catheter procedures among the ways to repair a simple defect of this kind when it does not heal by itself. No trial results are recorded here.

Product details

Type
Device
Model or formulation
Amplatzer Septal Occluder (ASO) and Amplatzer Exchange System
Version
The record read is the original 2001 approval. Later supplements are not read here.

Intended-use sources

  1. Background FDA premarket approval record P000039: Amplatzer Septal Occluder and Exchange System (original PMA approval) (openFDA record)

    Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P000039 (the earliest record by decision date, which is the original approval, with no supplement number), from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record. · PMA: P000039

    Locator
    Whole source
    How it applies
    Source of the stated intended use
    Retrieved
    Source effective date
    2026-10-05
    Source state
    Current
    Snapshot hash
    ff5d636a50d50cfd28b1ca78fcca5a6658ca09be5ce1eb48e76f199b2ec8844f
    Reuse basis
    openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P000039.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.

Claims and evidence

Context United States PMA approval P000039: Amplatzer Septal Occluder for secundum atrial septal defect

Recipient
Recipient not specified
Population
Patients with echocardiographic evidence of an ostium secundum atrial septal defect and clinical evidence of right ventricular volume overload, and patients who have had a fenestrated Fontan procedure and now need the fenestration closed. The order gives no age range.
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
Gestational age
Not reported
Postnatal age
Not reported
Follow-up
Not applicable (regulatory decision)
Eligibility: 3 inclusion criteria; exclusion criteria not stated
Included
  • Atrial septal defect in the secundum position, with echocardiographic evidence
  • Clinical evidence of right ventricular volume overload (a left-to-right shunt of 1.5:1 or right ventricular enlargement)
  • Or: a past fenestrated Fontan procedure that now needs the fenestration closed
Excluded
None stated

  • Description Evidence stage not applicable Certainty not assessed

    The Amplatzer Septal Occluder is FDA-approved for closing atrial septal defects in the secundum position through a catheter, in patients with echocardiographic evidence of an ostium secundum defect and clinical evidence of right ventricular volume overload (a left-to-right shunt of 1.5 to 1 or right ventricular enlargement). The approval order also covers closing the fenestration after a fenestrated Fontan procedure. This states what the device is approved for. It is not a finding about how well the device works or how safe it is.

    Applies to Recipient not specified
    • Patients with echocardiographic evidence of an ostium secundum atrial septal defect and clinical evidence of right ventricular volume overload, and patients who have had a fenestrated Fontan procedure and now need the fenestration closed. The order gives no age range.
    • Not stated in the FDA record
    • United States (decision by the US Food and Drug Administration)
    • Not stated in the FDA record
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up Not applicable (regulatory decision)
    Certainty method
    Not assessed
    Limitations
    Describes the approval scope only. The order cited gives no age range, no trial results and no comparison with surgery; the summary of safety and effectiveness was not read. The link to adult congenital heart disease is the atlas's filing of the record: the approval does not say the patients are adults, and the NHLBI pages describe atrial septal defects as defects present at birth.
    Last checked
    2026-10-14
    Next evidence check due
    Not scheduled
    Sources and citations (4)

    1. Supports FDA premarket approval record P000039: Amplatzer Septal Occluder and Exchange System (original PMA approval) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P000039 (the earliest record by decision date, which is the original approval, with no supplement number), from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record. · PMA: P000039

      Locator
      results[0].ao_statement
      How it applies
      The approval order statement: the approved indications.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      ff5d636a50d50cfd28b1ca78fcca5a6658ca09be5ce1eb48e76f199b2ec8844f
      Reuse basis
      openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P000039.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.

    2. Supports FDA premarket approval record P000039: Amplatzer Septal Occluder and Exchange System (original PMA approval) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P000039 (the earliest record by decision date, which is the original approval, with no supplement number), from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record. · PMA: P000039

      Locator
      results[0].decision_date
      How it applies
      Date of the approval.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      ff5d636a50d50cfd28b1ca78fcca5a6658ca09be5ce1eb48e76f199b2ec8844f
      Reuse basis
      openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P000039.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.

    3. Background Congenital Heart Defects: Types (NHLBI)

      Webpage · National Heart, Lung, and Blood Institute (NIH) · Edition Page fetched 2026-10-14. The page says it was last updated on March 24, 2022.

      Locator
      Atrial septal defect section
      How it applies
      NHLBI describes what an atrial septal defect is.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      9d927334f1b5cfb2fa5e6b3c8eddb6bad4bf0d633b0b7ff03f4281ef357a6588
      Reuse basis
      NHLBI is part of the U.S. National Institutes of Health. The pages carry third-party material, such as animations credited to Nucleus Medical Media, that this atlas does not use. NIH's own web policy page returned HTTP 403 to a script on 2026-10-14 (cj-nih-web-policies.html and cj-nih-web-policies-alt.html), and the NHLBI privacy and accessibility page (cj-nhlbi-privacy-accessibility.html) says nothing about reuse, so this atlas has not read NHLBI's own reuse terms. Public text is cite_only until they are read; the integration owner can change it to quote. Hash only; the page is not committed.

    4. Background Congenital Heart Defects: Treatment (NHLBI)

      Webpage · National Heart, Lung, and Blood Institute (NIH) · Edition Page fetched 2026-10-14. The page says it was last updated on March 24, 2022.

      Locator
      Procedures section
      How it applies
      NHLBI names cardiac catheterization as a way to repair a simple defect such as an atrial septal defect.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      2461de12d2112bac2ca9dc9b277263fbf6804c9ee8185d3d7d49a21deef6a8ca
      Reuse basis
      NHLBI is part of the U.S. National Institutes of Health. The pages carry third-party material, such as animations credited to Nucleus Medical Media, that this atlas does not use. NIH's own web policy page returned HTTP 403 to a script on 2026-10-14 (cj-nih-web-policies.html and cj-nih-web-policies-alt.html), and the NHLBI privacy and accessibility page (cj-nhlbi-privacy-accessibility.html) says nothing about reuse, so this atlas has not read NHLBI's own reuse terms. Public text is cite_only until they are read; the integration owner can change it to quote. Hash only; the page is not committed.

  • Regulatory Evidence stage not applicable Certainty not assessed

    On 2001-12-05 the US Food and Drug Administration approved the Amplatzer Septal Occluder (ASO) and the Amplatzer Exchange System under PMA P000039, product code MLV, applicant ABBOTT MEDICAL. The approval order states the occluder is indicated for occlusion of atrial septal defects in the secundum position, and also for patients who have had a fenestrated Fontan procedure and now need the fenestration closed. Patients indicated for atrial septal defect closure have echocardiographic evidence of an ostium secundum defect and clinical evidence of right ventricular volume overload (a left-to-right shunt of 1.5:1 or right ventricular enlargement). The Exchange System is for removing an Amplatzer delivery sheath and exchanging it for one of equal or larger diameter.

    Applies to Recipient not specified
    • Patients with echocardiographic evidence of an ostium secundum atrial septal defect and clinical evidence of right ventricular volume overload, and patients who have had a fenestrated Fontan procedure and now need the fenestration closed. The order gives no age range.
    • Not stated in the FDA record
    • United States (decision by the US Food and Drug Administration)
    • Not stated in the FDA record
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up Not applicable (regulatory decision)
    Certainty method
    Not assessed
    Limitations
    openFDA copies the approval order statement and may lose characters; where a symbol is missing it is not restored here. The FDA PMA database page, the approval order and the summary of safety and effectiveness were not read, so conditions of approval and trial results are not recorded. An approval is a regulatory decision and not a finding about how well the device works for any person. openFDA's own disclaimer says not to rely on it to make decisions regarding medical care. The order gives no age range. Closing the opening in a heart is also done by surgery; this record does not compare the two.
    Last checked
    2026-10-14
    Next evidence check due
    Not scheduled
    Sources and citations (8)

    1. Supports FDA premarket approval record P000039: Amplatzer Septal Occluder and Exchange System (original PMA approval) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P000039 (the earliest record by decision date, which is the original approval, with no supplement number), from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record. · PMA: P000039

      Locator
      results[0].pma_number
      How it applies
      The PMA number of this record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      ff5d636a50d50cfd28b1ca78fcca5a6658ca09be5ce1eb48e76f199b2ec8844f
      Reuse basis
      openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P000039.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.

    2. Supports FDA premarket approval record P000039: Amplatzer Septal Occluder and Exchange System (original PMA approval) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P000039 (the earliest record by decision date, which is the original approval, with no supplement number), from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record. · PMA: P000039

      Locator
      results[0].applicant
      How it applies
      The applicant, as FDA writes the name.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      ff5d636a50d50cfd28b1ca78fcca5a6658ca09be5ce1eb48e76f199b2ec8844f
      Reuse basis
      openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P000039.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.

    3. Supports FDA premarket approval record P000039: Amplatzer Septal Occluder and Exchange System (original PMA approval) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P000039 (the earliest record by decision date, which is the original approval, with no supplement number), from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record. · PMA: P000039

      Locator
      results[0].trade_name
      How it applies
      The trade name FDA gives this record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      ff5d636a50d50cfd28b1ca78fcca5a6658ca09be5ce1eb48e76f199b2ec8844f
      Reuse basis
      openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P000039.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.

    4. Supports FDA premarket approval record P000039: Amplatzer Septal Occluder and Exchange System (original PMA approval) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P000039 (the earliest record by decision date, which is the original approval, with no supplement number), from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record. · PMA: P000039

      Locator
      results[0].decision_date
      How it applies
      ISO date of the decision.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      ff5d636a50d50cfd28b1ca78fcca5a6658ca09be5ce1eb48e76f199b2ec8844f
      Reuse basis
      openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P000039.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.

    5. Supports FDA premarket approval record P000039: Amplatzer Septal Occluder and Exchange System (original PMA approval) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P000039 (the earliest record by decision date, which is the original approval, with no supplement number), from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record. · PMA: P000039

      Locator
      results[0].decision_code
      How it applies
      FDA decision code: APPR is an approval.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      ff5d636a50d50cfd28b1ca78fcca5a6658ca09be5ce1eb48e76f199b2ec8844f
      Reuse basis
      openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P000039.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.

    6. Supports FDA premarket approval record P000039: Amplatzer Septal Occluder and Exchange System (original PMA approval) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P000039 (the earliest record by decision date, which is the original approval, with no supplement number), from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record. · PMA: P000039

      Locator
      results[0].product_code
      How it applies
      FDA product code of this record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      ff5d636a50d50cfd28b1ca78fcca5a6658ca09be5ce1eb48e76f199b2ec8844f
      Reuse basis
      openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P000039.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.

    7. Supports FDA premarket approval record P000039: Amplatzer Septal Occluder and Exchange System (original PMA approval) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P000039 (the earliest record by decision date, which is the original approval, with no supplement number), from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record. · PMA: P000039

      Locator
      results[0].ao_statement
      How it applies
      FDA approval order statement: the approved indication, quoted in fragments.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      ff5d636a50d50cfd28b1ca78fcca5a6658ca09be5ce1eb48e76f199b2ec8844f
      Reuse basis
      openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P000039.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.

    8. Background FDA premarket approval record P000039: Amplatzer Septal Occluder and Exchange System (original PMA approval) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P000039 (the earliest record by decision date, which is the original approval, with no supplement number), from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record. · PMA: P000039

      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
      ff5d636a50d50cfd28b1ca78fcca5a6658ca09be5ce1eb48e76f199b2ec8844f
      Reuse basis
      openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P000039.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.

Authorization

Regulatory decision: Amplatzer Septal Occluder

Applies to Recipient not specified
  • Patients with echocardiographic evidence of an ostium secundum atrial septal defect and clinical evidence of right ventricular volume overload, and patients who have had a fenestrated Fontan procedure and now need the fenestration closed. The order gives no age range.
  • Not stated in the FDA record
  • United States (decision by the US Food and Drug Administration)
  • Not stated in the FDA record
  • 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
P000039
Product code
MLV
Device class
Class III
Jurisdictions
United States; note: United States
Product version
Amplatzer Septal Occluder (ASO) and Amplatzer Exchange System (original approval)
Indication
Occlusion of atrial septal defects in the secundum position (with echocardiographic evidence of an ostium secundum defect and clinical evidence of right ventricular volume overload), and closure of the fenestration in patients who have had a fenestrated Fontan procedure. The Exchange System is for exchanging an Amplatzer delivery sheath.
Basis
On 2001-12-05 the US Food and Drug Administration approved the Amplatzer Septal Occluder (ASO) and the Amplatzer Exchange System under PMA P000039, product code MLV, applicant ABBOTT MEDICAL. The approval order states the occluder is indicated for occlusion of atrial septal defects in the secundum position, and also for patients who have had a fenestrated Fontan procedure and now need the fenestration closed. Patients indicated for atrial septal defect closure have echocardiographic evidence of an ostium secundum defect and clinical evidence of right ventricular volume overload (a left-to-right shunt of 1.5:1 or right ventricular enlargement). The Exchange System is for removing an Amplatzer delivery sheath and exchanging it for one of equal or larger diameter.

Limitations. openFDA copies the approval order statement and may lose characters; where a symbol is missing it is not restored here. The FDA PMA database page, the approval order and the summary of safety and effectiveness were not read, so conditions of approval and trial results are not recorded. An approval is a regulatory decision and not a finding about how well the device works for any person. openFDA's own disclaimer says not to rely on it to make decisions regarding medical care. The order gives no age range. Closing the opening in a heart is also done by surgery; this record does not compare the two.

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:amplatzer-septal-occluder
Content hash
ffa15e5551a7adcbad746bfb55ba67ddb37c9e2753bbd7bd6f95f32e3ca9806e