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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 Transcatheter Heart Valve and Accessories
Generic NameAortic valve, prosthesis, percutaneously delivered
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP140031
Supplement NumberS090
Date Received07/16/2019
Decision Date08/15/2019
Product Code NPT 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate 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 a revision to the Instructions for Use (IFU) for the Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System with the Edwards SAPIEN 3 Ultra Delivery System to add a warning related to balloon burst during the valve deployment process.
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