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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 MAGNA BIOPROSTHESES MODELS 3000 AND 3000TFX
Classification Namereplacement heart-valve
Regulation Number870.3925
ApplicantEDWARDS LIFESCIENCES, LLC.
PMA NumberP860057
Supplement NumberS041
Date Received10/27/2006
Decision Date02/13/2007
Product Code
DYE[ Registered Establishments with DYE ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing process enhancement for the carpentier-edwards perimount pericardial aortic bioprosthesis models 3000 and 3000tfx polyester band/elgiloy band sub-assembly joining technique consisting of sewing through all of the band holes.
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