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+ Sysstem |
Generic Name | Aortic valve, prosthesis, percutaneously delivered |
Applicant | Medtronic, Inc. 710 Medtronic Parkway Minneapolis,, MN 55432 |
PMA Number | P130021 |
Supplement Number | S059 |
Date Received | 05/13/2019 |
Decision Date | 09/19/2019 |
Product Code |
NPT |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for various modifications to the CoreValve Evolut PRO System. The device, as modified, will be marketed under the trade name Evolut PRO+ System. |
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