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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 BIOSPROSTHETIC PULMONIC VALVED CONDUIT
Classification Namereplacement heart-valve
Generic Namebioprosthetic valved conduit
Regulation Number870.3925
ApplicantEDWARDS LIFESCIENCES, LLC.
PMA NumberP870056
Supplement NumberS060
Date Received06/17/2013
Decision Date07/16/2013
Product Code
DYE[ Registered Establishments with DYE ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Removal of a biological indicator requirement from the sterilization conventional release program to align with the latest version of the iso 14160 (2011) for liquid chemical sterilization.
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