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 TRANSCATHETER HEART VALVE AND ACCESSORIES
• Generic Name: Aortic valve, prosthesis, percutaneously delivered
• Applicant: EDWARDS LIFESCIENCES, LLC.; One Edwards Way; Irvine, CA 92614
• PMA Number: P140031
• Supplement Number: S010
• Date Received: 02/29/2016
• Decision Date: 08/18/2016
• Product Code: NPT
• Docket Number: 16M-2499
• Notice Date: 08/19/2016
• Advisory Committee: Cardiovascular
• Clinical Trials: NCT01314313
• Supplement Type: Panel Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: Yes
• Combination Product: No

Approval Order Statement  
Approval for the SAPIEN 3 Transcatheter Heart Valve and accessories for expanding the indication to include patients with intermediate surgical risk for aortic valve replacement. The device is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be at intermediate or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality >= 3% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the STS risk calculator).

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2
• Post-Approval Study: Show Report Schedule and Study Progress