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: SAPIEN 3 Pulmonic Delivery System (S3 PDS)
• Generic Name: Pulmonary valve prosthesis percutaneously delivered
• Applicant: Edwards Lifesciences, LLC; One Edwards Way; Irvine, CA 92614
• PMA Number: P200015
• Supplement Number: S039
• Date Received: 05/01/2023
• Decision Date: 05/30/2023
• Product Code: NPV
• 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  
Residual testing for the 20 kg weight classification in the pulmonic population for an alternative ethylene oxide sterilization cycle.