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 | S018 |
Date Received | 10/02/2020 |
Decision Date | 10/22/2020 |
Product Code |
LWR |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for an updated protocol and additional testing performed for shelf-life extension. |
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