| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | EDWARDS SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System |
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| Generic Name | Aortic valve, prosthesis, percutaneously delivered |
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| Applicant | Edwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614 |
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| PMA Number | P140031 |
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| Supplement Number | S112 |
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| Date Received | 03/16/2020 |
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| Decision Date | 09/09/2020 |
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| Product Code |
NPT |
| Docket Number | 20M-1868 |
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| Notice Date | 09/10/2020 |
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| Advisory Committee |
Cardiovascular |
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| Supplement Type | Panel Track |
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| Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
Approval for the Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System. This device is indicated for patients with symptomatic heart disease due to failing (stenosed, insufficient, or combined) of a surgical or transcatheter bioprosthetic aortic valve or a surgical bioprosthetic mitral valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality greater than or equal to 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the STS risk calculator). |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
Labeling Part 2 |
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| Post-Approval Study | Show Report Schedule and Study Progress |
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