Premarket Approval (PMA)

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.

• 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
• 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
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Increased manning and a relocation of component manufacturing activities to cleanroom #2-1.