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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 Magna Pericardial Aortic Bioprostheses
Generic Namereplacement Heart-valve
Regulation Number870.3925
ApplicantEDWARDS LIFESCIENCES, LLC.
One Edwards Way
Irvine, CA 92614
PMA NumberP860057
Supplement NumberS202
Date Received07/20/2021
Decision Date12/13/2021
Product Code DYE 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for the manufacturing of the Carpentier-Edwards PERIMOUNT Magna Pericardial Aortic Bioprosthesis (MAGNA Model 3300TFX) at the Edwards Cartago, Costa Rica Facility, limited to cleaning and sterilization of components, bioburden reduction, final assembly, terminal liquid sterilization, and packaging and labeling prior to commercial release.
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