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 SAPIEN TRANSCATHETER HEART VALVE (THV)
• Generic Name: aortic valve, prosthesis, percutaneously delivered
• Applicant: EDWARDS LIFESCIENCES, LLC.; one edwards way; irvine, CA 92614
• PMA Number: P100041
• Supplement Number: S009
• Date Received: 04/23/2012
• Decision Date: 05/09/2012
• Withdrawal Date: 03/18/2019
• Product Code: NPT
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
ALTERNATE RECEIVING INSPECTION SITE.