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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 MITRA & AORTIC,THEON,RSR,THEON RSR,MAGNA,MAGNA EASE WITH& WITHOUT THERMAFEX TISSUE PROCESS
Classification Namereplacement heart-valve
Regulation Number870.3925
ApplicantEDWARDS LIFESCIENCES, LLC.
PMA NumberP860057
Supplement NumberS128
Date Received09/04/2014
Decision Date10/02/2014
Product Code
DYE[ Registered Establishments with DYE ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change from porcine to bovine tissue in the post-sterilization testing.
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