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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(R) BIOPROSTHESIS, MODELS 2625 AND 6625
Generic Namereplacement Heart-valve
Regulation Number870.3925
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP870056
Supplement NumberS003
Date Received04/17/1996
Decision Date10/17/1996
Withdrawal Date01/28/2022
Product Code DYE 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
MODIFICATION OF YOUR STERILIZATION PROCES TO REMOVE AN ASEPTIC STERILANT-TO-STORAGE TRANSFER PROCESS TO REMOVE AN ASEPTIC STERILANT-TO-STORAGE TRANSFER PROCESS AND REPLACE IT WITH A TERMINAL STERILIZATION PROCESS
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