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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 NumberS084
Date Received10/18/2024
Decision Date11/14/2024
Product Code LWR 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
increased manning in the GLX Processing Room located in Cleanroom #6 suite at the Singapore facility, and direct personnel access between the GLX Processing Room and the adjacent Inspection Room
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