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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 BIOPROSTHETIC VALVED CONDUIT
Generic Namereplacement Heart-valve
Regulation Number870.3925
ApplicantEDWARDS LIFESCIENCES, LLC.
One Edwards Way
Irvine, CA 92614
PMA NumberP870056
Supplement NumberS006
Date Received02/25/1998
Decision Date08/07/1998
Withdrawal Date 01/28/2022
Product Code DYE 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for adding the Model 4300 valved conduit and is indicated for correction of pulmonary stenosis or atresia and complex congenital malformations requiring Rastelli-type operations, and for correction of tricuspid atresia.
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