| 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 | CoreValve System; CoreValve Evolut R System; CoreValve Evolut PRO System |
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| Generic Name | Aortic valve, prosthesis, percutaneously delivered |
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| Applicant | Medtronic, Inc.
710 Medtronic Parkway
Minneapolis,, MN 55432 |
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| PMA Number | P130021 |
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| Supplement Number | S033 |
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| Date Received | 03/06/2017 |
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| Decision Date | 07/10/2017 |
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| Product Code |
NPT |
| Docket Number | 17M-4271 |
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| Notice Date | 07/18/2017 |
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| Advisory Committee |
Cardiovascular |
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| Clinical Trials | NCT01586910
|
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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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Approval Order Statement
Approval for the Medtronic CoreValve System, CoreValve Evolut R System, and CoreValve Evolut PRO System. The devices are indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be at intermediate or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality >= 3% 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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