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 AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES
• Generic Name: Aortic valve, prosthesis, percutaneously delivered
• Applicant: EDWARDS LIFESCIENCES LLC.; One Edwards Way; Irvine, CA 92614
• PMA Number: P110021
• Supplement Number: S026
• Date Received: 08/28/2013
• Decision Date: 09/23/2013
• Withdrawal Date: 03/18/2019
• Product Code: NPT
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
APPROVAL FOR REMOVAL OF ACCESS APPROACH FROM DEVICE LABELING. THE DEVICE IS INDICATED FOR PATIENTS WITH SEVERE SYMPTOMATIC CALCIFIED NATIVE AORTIC VALVE STENOSIS WITHOUT SEVERE AORTIC INSUFFICIENCY AND WITH EJECTION FRACTION > 20% WHO HAVE BEEN EXAMINED BY A HEART TEAM INCLUDING AN EXPERIENCED CARDIAC SURGEON AND A CARDIOLOGIST AND FOUND TO BE: 1) INOPERABLE AND IN WHOM EXISTING CO-MORBIDITIES WOULD NOT PRECLUDE THE EXPECTED BENEFIT FROM CORRECTION OF THE AORTIC STENOSIS; OR 2) BE OPERATIVE CANDIDATES FOR AORTIC VALVE REPLACEMENT BUT WHO HAVE A PREDICTED OPERATIVE RISK SCORE >= 8% OR ARE JUDGED BY THE HEART TEAM TO BE AT A >= 15% RISK OF MORTALITY FOR SURGICAL AORTIC VALVE REPLACEMENT.