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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameCARPENTIER-EDWARDS VALVED CONDUIT, MODEL 4300
Classification Namereplacement heart-valve
Generic Namebioprosthetic valved conduit
Regulation Number870.3925
ApplicantEDWARDS LIFESCIENCES, LLC.
PMA NumberP870056
Supplement NumberS047
Date Received03/05/2012
Decision Date04/04/2012
Product Code
DYE[ Registered Establishments with DYE ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
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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