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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 Pericardial Aortic Bioprosthesis and INSPIRIS RESILIA Aortic Valve
Generic Nameheart-valve, non-allograft tissue
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP150048
Supplement NumberS060
Date Received02/04/2022
Decision Date12/29/2022
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 35 Changi North Crescent, Changi, Singapore, 499641 for RESILIA/GLX processing and final packaging of the INSPIRIS RESILIA Aortic Valves, as well as an alternate ethylene oxide sterilization site at Sterile Services Singapore, 47 Jaran Buroh Unit #01-01, Singapore South West, Singapore 619491.
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