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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 BIOPROSTHESIS MODELS
Classification Namereplacement heart-valve
Regulation Number870.3925
ApplicantEDWARDS LIFESCIENCES, LLC.
PMA NumberP860057
Supplement NumberS062
Date Received11/06/2009
Decision Date01/05/2010
Product Code
DYE[ Registered Establishments with DYE ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for elimination of stent creep testing from the shelf life testing protocol for the perimount bioprosthetic valves treated with the thermafix process.
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