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: Injection Molding Crimper 9600CR Components
• Generic Name: Aortic valve, prosthesis, percutaneously delivered
• Applicant: Edwards Lifesciences, LLC; One Edwards Way; Irvine, CA 92614
• PMA Number: P140031
• Supplement Number: S176
• Date Received: 07/29/2024
• Decision Date: 08/12/2024
• Product Code: NPT
• 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  
implementing in-house injection molding of crimper components