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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.
 
DeviceCarpentier-Edwards PERIMOUNT Theon RSR Pericardial Aortic Bioprosthesis with ThermaFix® tissue process, Carpentier-Edwar
Generic Namereplacement Heart-valve
Regulation Number870.3925
ApplicantEDWARDS LIFESCIENCES, LLC.
One Edwards Way
Irvine, CA 92614
PMA NumberP860057
Supplement NumberS212
Date Received03/29/2023
Decision Date04/27/2023
Product Code DYE 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Transfer of receiving inspection activities for non-biological pericardial valve components from the Edwards Irvine facility to the Edwards Singapore facility.
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