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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
 
DeviceEdwards SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES
Classification Nameaortic valve, prosthesis, percutaneously delivered
Generic Nameaortic valve, prosthesis, percutaneously delivered
Applicant
EDWARDS LIFESCIENCES, LLC.
one edwards way
irvine, CA 92614
PMA NumberP140031
Supplement NumberS028
Date Received12/09/2016
Decision Date06/05/2017
Product Code
NPT[ Registered Establishments with NPT ]
Docket Number 17M-3579
Notice Date 06/09/2017
Advisory Committee Cardiovascular
Supplement Typepanel 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. The device is indicated for patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic or mitral valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality greater than or equal to 8% at 30 days, based on the 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 StudyShow Report Schedule and Study Progress
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