| 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 | Evolut PRO+ System, Evolut FX System, Evolut FX+ System |
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| Generic Name | Aortic valve, prosthesis, percutaneously delivered |
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| Applicant | Medtronic, Inc.
710 Medtronic Pkwy.
Miinneapolis, MN 55432 |
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| PMA Number | P130021 |
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| Supplement Number | S174 |
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| Date Received | 02/28/2025 |
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| Decision Date | 08/27/2025 |
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| Product Code |
NPT |
| Docket Number | 25M-3437 |
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| Notice Date | 08/29/2025 |
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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 Evolut PRO+ System, Evolut FX System, Evolut FX+ System for expanding the indications to include the treatment of patients with a failed trascatheter aortic valve who are at high or greater risk of mortality from open surgical therapy. This device is indicated for use in patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical or transcatheter bioprosthetic aortic 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 >8% at 30 days, based on the 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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