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 XT Transcatheter Heart Valve and Accessories
• Generic Name: Aortic valve, prosthesis, percutaneously delivered
• Applicant: Edwards Lifesciences, LLC; One Edwards Way; Irvine, CA 92614
• PMA Number: P130009
• Supplement Number: S100
• Date Received: 08/30/2019
• Decision Date: 09/17/2019
• Product Code: NPT
• Advisory Committee: Cardiovascular
• Supplement Type: Special (Immediate Track)
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for the introduction of 100% visual inspection of the Sapien XT introducer sheath.