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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 DURAFLEX LOW PRESSURE, PORCINBE MITRAL BIOPROSTHESIS
Classification Namereplacement heart-valve
Generic Nameheart valve for mitral valve replacement
Regulation Number870.3925
ApplicantEDWARDS LIFESCIENCES, LLC.
PMA NumberP870077
Supplement NumberS052
Date Received02/12/2013
Decision Date03/12/2013
Product Code
DYE[ Registered Establishments with DYE ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for additional visual inspection steps for and removal, if found, of fibers and particles on sub-assembled and final assembled replacement heart valves prior to packaging.
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