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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 PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS
Generic Namereplacement Heart-valve
Regulation Number870.3925
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP000007
Supplement NumberS039
Date Received02/13/2013
Decision Date03/12/2013
Withdrawal Date01/28/2022
Product Code DYE 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR ADDITIONAL VISUAL INSPECTION STEPS FOR AND REMOVAL, IF FOUND, OF FIBERS AND PARTICLES ON SUB-ASSEMBLED AND FINAL ASSEMBLED REPLACEMENT HEART VALVES PRIOR TO PACKAGING.
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