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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS
Generic Namereplacement Heart-valve
Regulation Number870.3925
ApplicantEDWARDS LIFESCIENCES, LLC.
One Edwards Way
Irvine, CA 92614
PMA NumberP860057
Supplement NumberS053
Date Received12/17/2008
Decision Date12/08/2009
Product Code DYE 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR HARMONIZING THE CENTRAL HOLE DIAMETER, HARMONIZING THE WIREFORM CUSP DIAMETER AND ADDING AORTIC COMMISSURE TIP ANGLE AND COMMISSURE TIP RADIUS INSPECTIONS.
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