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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 Ultra RESILIA Transcatheter Heart Valve
Generic NameAortic valve, prosthesis, percutaneously delivered
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP140031
Supplement NumberS189
Date Received04/28/2025
Decision Date02/03/2026
Product Code NPT 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site located at Edwards Lifesciences Costa Rica S.R.L. for RESILIA tissue processing and at Sterigenics Costa Rica S.R.L. for ethylene oxide sterilization.
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