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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.
 
DeviceINSPIRIS RESILIA Aortic Valve; MITRIS RESILIA Mitral Valve
Generic Nameheart-valve, non-allograft tissue
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP150048
Supplement NumberS100
Date Received04/17/2026
Decision Date10/22/2026
Product Code LWR 
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 CENTERPIECE (Bulevar La Encantada Industrial, Parque Industrial El Floride, Seccion La Encantada # 11530, Tijuana Baja California, Mexico 22250) for terminal ethylene oxide sterilization.
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