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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 BIOPROSTHETIC VALVED CONDUIT
Classification Namereplacement heart-valve
Generic Namebioprosthetic valved conduit
Regulation Number870.3925
ApplicantEDWARDS LIFESCIENCES, LLC.
PMA NumberP870056
Supplement NumberS006
Date Received02/25/1998
Decision Date08/07/1998
Product Code
DYE[ Registered Establishments with DYE ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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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