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 | Edwards Pericardial Aortic Bioprosthesis, INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Mitral Bioprosthesis, and t |
Generic Name | heart-valve, non-allograft tissue |
Applicant | EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY IRVINE, CA 92614-5688 |
PMA Number | P150048 |
Supplement Number | S058 |
Date Received | 09/27/2021 |
Decision Date | 10/12/2021 |
Product Code |
LWR |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Increased manning and a relocation of component manufacturing activities to cleanroom #2-1. |
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