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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 INSPIRIS RESILIA Aortic Valve and Edwards Pericardial Aortic Bioprosthesis
Generic Nameheart-valve, non-allograft tissue
ApplicantEDWARDS LIFESCIENCES, LLC.
ONE EDWARDS WAY
IRVINE, CA 92614-5688
PMA NumberP150048
Supplement NumberS007
Date Received10/31/2017
Decision Date11/27/2017
Product Code LWR 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Addition of a new cleanroom adjacent to an existing cleanroom.
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