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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, KONECT RESILIA Aortic Valve Conduit (AVC), MITRIS RESILIA Mitral Valve
Generic Nameheart-valve, non-allograft tissue
ApplicantEDWARDS LIFESCIENCES, LLC.
ONE EDWARDS WAY
IRVINE, CA 92614-5688
PMA NumberP150048
Supplement NumberS077
Date Received11/16/2023
Decision Date01/16/2024
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
Approval Order Statement  
approval for a sterilization manufacturing site located at Steris Applied Sterilization Technologies (AST), Isomedix Operations, Inc., 43425 Business Park Drive Temecula, California 92590
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