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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 PORCINE STENTLESS BIOPROSTHETIC VALVES
Generic Namereplacement Heart-valve
Regulation Number870.3925
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP010041
Supplement NumberS025
Date Received11/22/2010
Decision Date12/22/2010
Withdrawal Date01/28/2022
Product Code DYE 
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  
USE OF ADDITIONAL STERILIZATION EQUIPMENT AND MINOR CHANGES TO STERILIZATION CYCLE.
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