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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.
 
DeviceSAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valves
Generic NameAortic valve, prosthesis, percutaneously delivered
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP140031
Supplement NumberS087
Date Received05/17/2019
Decision Date07/29/2019
Product Code NPT 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for updates to the labeling of the SAPIEN 3 Transcatheter Heart Valve and Accessories and SAPIEN 3 Ultra Transcatheter Heart Valve and Accessories regarding additional valve-in-valve sizing guidance for implantation inside the Edwards INSPIRIS RESILIA aortic valve model 11500A.
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