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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 PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIO
Classification Namereplacement heart-valve
Regulation Number870.3925
ApplicantEDWARDS LIFESCIENCES, LLC.
PMA NumberP860057
Supplement NumberS101
Date Received12/14/2012
Decision Date01/08/2013
Product Code
DYE
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Software modification to the automated mixing, storage and delivery system used in the manufacture of several models of the carpentier-edwards perimount aortic and mitral valve bioprostheses.
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