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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
Classification Namereplacement heart-valve
Generic Namereplacement heart-valve
Regulation Number870.3925
Applicant
EDWARDS LIFESCIENCES, LLC.
one edwards way
irvine, CA 92614
PMA NumberP870056
Supplement NumberS023
Date Received11/14/2005
Decision Date12/06/2005
Product Code
DYE[ Registered Establishments with DYE ]
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
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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