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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 VALVED CONDUIT, MODEL 4300
Generic Namereplacement Heart-valve
Regulation Number870.3925
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP870056
Supplement NumberS047
Date Received03/05/2012
Decision Date04/04/2012
Withdrawal Date01/28/2022
Product Code DYE 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR ADDING TEXT TO THE WARNINGS AND COMPLICATIONS SECTIONS OF THE EDWARDS MODEL 4300 VALVED CONDUIT IFU IN ORDER TO STRENGTHEN THESE STATEMENTS.
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