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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 BIOPROSTHESES, MODELS 2625 (AORTIC) & 6625 (MITRAL), AND CARPENTIER-EDWARDS BIOPROSTHETIC VALVED COND
Generic Namereplacement Heart-valve
Regulation Number870.3925
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP870056
Supplement NumberS015
Date Received11/12/2002
Decision Date08/22/2003
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  
APPROVAL FOR THE REPLACEMENT OF THE PACKAGE TEMPERATURE INDICATOR TO THE TAGALERTNIC TEMPERATURE INDICATOR (HIGH AND LOW).
Post-Approval StudyShow Report Schedule and Study Progress
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