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 | Avalus Bioprosthesis |
Generic Name | heart-valve, non-allograft tissue |
Applicant | Medtronic Inc. 1851 E. Deere Avenue Santa Ana, CA 92705 |
PMA Number | P170006 |
Supplement Number | S024 |
Date Received | 08/30/2023 |
Decision Date | 01/08/2024 |
Product Code |
LWR |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT02088554
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Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to add a 29mm size of the Avalus bioprosthesis |
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