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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 BIOPROSTHESIS,MODELS 2625 & 6625
Generic Namereplacement Heart-valve
Regulation Number870.3925
ApplicantEDWARDS LIFESCIENCES, LLC.
One Edwards Way
Irvine, CA 92614
PMA NumberP870056
Supplement NumberS023
Date Received11/14/2005
Decision Date12/06/2005
Withdrawal Date 01/28/2022
Product Code DYE 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF AN INSPECTION FOR THE 3.8 OZ JAR USED TO PACKAGE THE BIOPROSTHETIC HEART VALVES.
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