Cardiovascular Atlas
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SAPIEN 3 transcatheter heart valve

A replacement aortic valve from Edwards Lifesciences that is put in through a catheter, a procedure called TAVR. The US FDA approved it in 2015 for people with severe aortic stenosis who a heart team judged to be at high or greater risk from open-heart surgery, and in 2019 widened the approval to people at low surgical risk. It is the valve tested in the PARTNER 3 and EARLY TAVR trials.

Also called Edwards SAPIEN 3 · SAPIEN 3 Ultra · SAPIEN 3 THV

  • Product
  • In this atlas

Overview

Technical summary

Edwards SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valves, FDA product code NPT. Original approval: PMA P140031, 2015-06-17, model 9600TFX and accessories, high or greater surgical risk. Supplement S085, 2019-08-16, names the SAPIEN 3 and SAPIEN 3 Ultra systems and adds people for whom the risk of surgical aortic valve replacement is low. The PARTNER 3 and EARLY TAVR abstracts describe a balloon-expandable valve placed through the femoral artery; the EARLY TAVR registry record names the SAPIEN 3 and SAPIEN 3 Ultra valves. Between the two approvals FDA made many other supplements that are not read here.

Product details

Type
Device
Model or formulation
SAPIEN 3 (model 9600TFX in the original approval) and SAPIEN 3 Ultra
Version
The original approval names model 9600TFX and accessories. The 2019 supplement names the SAPIEN 3 and SAPIEN 3 Ultra systems. Other models and supplements are not read here.

Intended-use sources

  1. Background FDA premarket approval record P140031: Edwards SAPIEN 3 transcatheter heart valve (original PMA approval) (openFDA record)

    Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P140031 (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: P140031

    Locator
    Whole source
    How it applies
    Source of the stated intended use
    Retrieved
    Source effective date
    2026-10-05
    Source state
    Current
    Snapshot hash
    49b88c10c4d4845b8a93c03a6fc3a9656d4c50f0f693f573b178386e2b68fa90
    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-P140031.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. Background FDA premarket approval record P140031/S085: SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valves (PMA supplement S085, low-risk indication) (openFDA record)

    Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P140031 supplement S085, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.

    Locator
    Whole source
    How it applies
    Source of the stated intended use
    Retrieved
    Source effective date
    2026-10-05
    Source state
    Current
    Snapshot hash
    eab40c1bd1d2ae0e51447f84a647187385b49dba86b806ac7dd9bd2cdf45e537
    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-P140031-S085.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 P140031: SAPIEN 3 for severe aortic stenosis at high or greater surgical risk

Recipient
Recipient not specified
Population
People with heart disease with symptoms caused by severe calcific narrowing of their own (native) aortic valve whom a heart team that includes a cardiac surgeon judges to face a high or greater risk from open surgery. The order gives no age range.
Care setting
Not stated in the FDA record beyond the heart team judgement
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: 2 inclusion criteria; exclusion criteria not stated
Included
  • Heart disease with symptoms caused by severe calcific narrowing of the person's own (native) aortic valve
  • A heart team that includes a cardiac surgeon judges the person to face a high or greater risk from open surgery (Society of Thoracic Surgeons operative risk score of 8% or more, or a risk of mortality at 30 days of 15% or more, per the summary of safety and effectiveness)
Excluded
None stated

  • Regulatory Evidence stage not applicable Certainty not assessed

    On 2015-06-17 the US Food and Drug Administration approved the Edwards SAPIEN 3 transcatheter heart valve, model 9600TFX, and its accessories under PMA P140031, product code NPT, applicant Edwards Lifesciences, LLC. According to the approval order, the valve is for easing aortic stenosis in people with heart disease with symptoms caused by severe calcific narrowing of their own (native) aortic valve, whom a heart team that includes a cardiac surgeon judges to face a high or greater risk from open surgery. The summary of safety and effectiveness gives the measure of that risk as a Society of Thoracic Surgeons operative risk score of 8% or more, or a risk of mortality at 30 days of 15% or more. The openFDA text of the order prints no comparison symbol, so those readings come from the summary.

    Applies to Recipient not specified
    • People with heart disease with symptoms caused by severe calcific narrowing of their own (native) aortic valve whom a heart team that includes a cardiac surgeon judges to face a high or greater risk from open surgery. The order gives no age range.
    • Not stated in the FDA record beyond the heart team judgement
    • 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. This original approval covers high or greater surgical risk only. Later supplements widened the indication (the low-risk supplement S085 has its own record; other supplements are not read here).
    Last checked
    2026-10-14
    Next evidence check due
    Not scheduled
    Sources and citations (9)

    1. Supports FDA premarket approval record P140031: Edwards SAPIEN 3 transcatheter heart valve (original PMA approval) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P140031 (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: P140031

      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
      49b88c10c4d4845b8a93c03a6fc3a9656d4c50f0f693f573b178386e2b68fa90
      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-P140031.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 P140031: Edwards SAPIEN 3 transcatheter heart valve (original PMA approval) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P140031 (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: P140031

      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
      49b88c10c4d4845b8a93c03a6fc3a9656d4c50f0f693f573b178386e2b68fa90
      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-P140031.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 P140031: Edwards SAPIEN 3 transcatheter heart valve (original PMA approval) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P140031 (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: P140031

      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
      49b88c10c4d4845b8a93c03a6fc3a9656d4c50f0f693f573b178386e2b68fa90
      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-P140031.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 P140031: Edwards SAPIEN 3 transcatheter heart valve (original PMA approval) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P140031 (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: P140031

      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
      49b88c10c4d4845b8a93c03a6fc3a9656d4c50f0f693f573b178386e2b68fa90
      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-P140031.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 P140031: Edwards SAPIEN 3 transcatheter heart valve (original PMA approval) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P140031 (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: P140031

      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
      49b88c10c4d4845b8a93c03a6fc3a9656d4c50f0f693f573b178386e2b68fa90
      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-P140031.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 P140031: Edwards SAPIEN 3 transcatheter heart valve (original PMA approval) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P140031 (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: P140031

      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
      49b88c10c4d4845b8a93c03a6fc3a9656d4c50f0f693f573b178386e2b68fa90
      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-P140031.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 P140031: Edwards SAPIEN 3 transcatheter heart valve (original PMA approval) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P140031 (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: P140031

      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
      49b88c10c4d4845b8a93c03a6fc3a9656d4c50f0f693f573b178386e2b68fa90
      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-P140031.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 P140031: Edwards SAPIEN 3 transcatheter heart valve (original PMA approval) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P140031 (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: P140031

      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
      49b88c10c4d4845b8a93c03a6fc3a9656d4c50f0f693f573b178386e2b68fa90
      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-P140031.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.

    9. Supports FDA summary of safety and effectiveness data for PMA P140031 (SAPIEN 3)

      Regulator · U.S. Food and Drug Administration · Edition PDF fetched 2026-10-14; text read with pdftotext. The decision document of the FDA PMA database.

      Locator
      Section II, Indications for use
      How it applies
      The summary of safety and effectiveness prints the risk thresholds with their comparison symbols, which openFDA drops.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      86e0727ff92121d593272b44d17318e6df64030b4c9e72263360c33d20249fb1
      Reuse basis
      FDA document fetched 2026-10-14 from accessdata.fda.gov. FDA's own website reuse terms were not read for this atlas, so public text is cite_only until they are. Hash only; the PDF is not committed.

Context United States PMA supplement P140031 S085: SAPIEN 3 for severe aortic stenosis at low surgical risk

Recipient
Recipient not specified
Population
People with heart disease with symptoms caused by severe calcific narrowing of their own (native) aortic valve whom a heart team that includes a cardiac surgeon judges suitable for transcatheter heart valve replacement, including people for whom the risk of surgical aortic valve replacement is low. The order gives no age range.
Care setting
Not stated in the FDA record beyond the heart team judgement
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: 2 inclusion criteria; exclusion criteria not stated
Included
  • Heart disease with symptoms caused by severe calcific narrowing of the person's own (native) aortic valve
  • A heart team that includes a cardiac surgeon judges transcatheter heart valve replacement suitable for the person
Excluded
None stated

  • Regulatory Evidence stage not applicable Certainty not assessed

    On 2019-08-16 the US Food and Drug Administration approved PMA supplement S085 to P140031, applicant Edwards Lifesciences, LLC, for the Edwards SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valve systems. The supplement widens the use of these valves to people for whom the risk of surgical aortic valve replacement is low. The use it describes is easing aortic stenosis in people with heart disease with symptoms caused by severe calcific narrowing of their own (native) aortic valve, whom a heart team that includes a cardiac surgeon judges suitable for transcatheter heart valve replacement. The openFDA record lists the supplement type as Panel Track and the reason as a labeling change to the indications, instructions, shelf life or trade name.

    Applies to Recipient not specified
    • People with heart disease with symptoms caused by severe calcific narrowing of their own (native) aortic valve whom a heart team that includes a cardiac surgeon judges suitable for transcatheter heart valve replacement, including people for whom the risk of surgical aortic valve replacement is low. The order gives no age range.
    • Not stated in the FDA record beyond the heart team judgement
    • 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 openFDA record does not name the trial behind the supplement, so this record does not link the supplement to PARTNER 3.
    Last checked
    2026-10-14
    Next evidence check due
    Not scheduled
    Sources and citations (10)

    1. Supports FDA premarket approval record P140031/S085: SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valves (PMA supplement S085, low-risk indication) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P140031 supplement S085, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.

      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
      eab40c1bd1d2ae0e51447f84a647187385b49dba86b806ac7dd9bd2cdf45e537
      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-P140031-S085.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 P140031/S085: SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valves (PMA supplement S085, low-risk indication) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P140031 supplement S085, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.

      Locator
      results[0].supplement_number
      How it applies
      The supplement number of this record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      eab40c1bd1d2ae0e51447f84a647187385b49dba86b806ac7dd9bd2cdf45e537
      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-P140031-S085.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 P140031/S085: SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valves (PMA supplement S085, low-risk indication) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P140031 supplement S085, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.

      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
      eab40c1bd1d2ae0e51447f84a647187385b49dba86b806ac7dd9bd2cdf45e537
      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-P140031-S085.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 P140031/S085: SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valves (PMA supplement S085, low-risk indication) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P140031 supplement S085, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.

      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
      eab40c1bd1d2ae0e51447f84a647187385b49dba86b806ac7dd9bd2cdf45e537
      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-P140031-S085.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 P140031/S085: SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valves (PMA supplement S085, low-risk indication) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P140031 supplement S085, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.

      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
      eab40c1bd1d2ae0e51447f84a647187385b49dba86b806ac7dd9bd2cdf45e537
      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-P140031-S085.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 P140031/S085: SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valves (PMA supplement S085, low-risk indication) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P140031 supplement S085, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.

      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
      eab40c1bd1d2ae0e51447f84a647187385b49dba86b806ac7dd9bd2cdf45e537
      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-P140031-S085.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 P140031/S085: SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valves (PMA supplement S085, low-risk indication) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P140031 supplement S085, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.

      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
      eab40c1bd1d2ae0e51447f84a647187385b49dba86b806ac7dd9bd2cdf45e537
      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-P140031-S085.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. Supports FDA premarket approval record P140031/S085: SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valves (PMA supplement S085, low-risk indication) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P140031 supplement S085, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.

      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
      eab40c1bd1d2ae0e51447f84a647187385b49dba86b806ac7dd9bd2cdf45e537
      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-P140031-S085.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.

    9. Background FDA premarket approval record P140031/S085: SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valves (PMA supplement S085, low-risk indication) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P140031 supplement S085, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.

      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
      eab40c1bd1d2ae0e51447f84a647187385b49dba86b806ac7dd9bd2cdf45e537
      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-P140031-S085.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.

    10. Supports FDA approval order for PMA supplement P140031/S085 (SAPIEN 3 and SAPIEN 3 Ultra, low-risk indication)

      Regulator · U.S. Food and Drug Administration · Edition PDF fetched 2026-10-14; text read with pdftotext. The decision document of the FDA PMA database. · PMA: P140031/S085

      Locator
      page 1, Re: line
      How it applies
      The FDA approval order names the supplement as P140031/S085.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      fb07accd6aed264d9a2ddd878453dc574ad73aece638424c9f108c35bb39a464
      Reuse basis
      FDA document fetched 2026-10-14 from accessdata.fda.gov. FDA's own website reuse terms were not read for this atlas, so public text is cite_only until they are. Hash only; the PDF is not committed.

Authorization

Regulatory decision: SAPIEN 3 transcatheter heart valve

Applies to Recipient not specified
  • People with heart disease with symptoms caused by severe calcific narrowing of their own (native) aortic valve whom a heart team that includes a cardiac surgeon judges suitable for transcatheter heart valve replacement, including people for whom the risk of surgical aortic valve replacement is low. The order gives no age range.
  • Not stated in the FDA record beyond the heart team judgement
  • 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
Supplemental approval,
Pathway
PMA
Submission
P140031/S085
Product code
NPT
Device class
Class III
Jurisdictions
United States; note: United States
Product version
SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valve systems (PMA supplement S085)
Indication
PMA supplement S085 expands the indication to include patients at low risk for surgical aortic valve replacement, for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis whom a heart team, including a cardiac surgeon, judges appropriate for transcatheter heart valve replacement.
Basis
On 2019-08-16 the US Food and Drug Administration approved PMA supplement S085 to P140031, applicant Edwards Lifesciences, LLC, for the Edwards SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valve systems. The supplement widens the use of these valves to people for whom the risk of surgical aortic valve replacement is low. The use it describes is easing aortic stenosis in people with heart disease with symptoms caused by severe calcific narrowing of their own (native) aortic valve, whom a heart team that includes a cardiac surgeon judges suitable for transcatheter heart valve replacement. The openFDA record lists the supplement type as Panel Track and the reason as a labeling change to the indications, instructions, shelf life or trade name.

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 openFDA record does not name the trial behind the supplement, so this record does not link the supplement to PARTNER 3.

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

Regulatory decision: SAPIEN 3 transcatheter heart valve

Applies to Recipient not specified
  • People with heart disease with symptoms caused by severe calcific narrowing of their own (native) aortic valve whom a heart team that includes a cardiac surgeon judges to face a high or greater risk from open surgery. The order gives no age range.
  • Not stated in the FDA record beyond the heart team judgement
  • 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
P140031
Product code
NPT
Device class
Class III
Jurisdictions
United States; note: United States
Product version
Edwards SAPIEN 3 transcatheter heart valve, model 9600TFX, and accessories (original approval)
Indication
Relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis whom a heart team, including a cardiac surgeon, judges to be at high or greater risk for open surgical therapy.
Basis
On 2015-06-17 the US Food and Drug Administration approved the Edwards SAPIEN 3 transcatheter heart valve, model 9600TFX, and its accessories under PMA P140031, product code NPT, applicant Edwards Lifesciences, LLC. According to the approval order, the valve is for easing aortic stenosis in people with heart disease with symptoms caused by severe calcific narrowing of their own (native) aortic valve, whom a heart team that includes a cardiac surgeon judges to face a high or greater risk from open surgery. The summary of safety and effectiveness gives the measure of that risk as a Society of Thoracic Surgeons operative risk score of 8% or more, or a risk of mortality at 30 days of 15% or more. The openFDA text of the order prints no comparison symbol, so those readings come from the summary.

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. This original approval covers high or greater surgical risk only. Later supplements widened the indication (the low-risk supplement S085 has its own record; other supplements are not read here).

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

Record details

Record id
cardio:sapien-3
Content hash
91727267cc48895bb12ceb9dd406729efdd88d136fd502c5363d182df44b80b6