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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(R) DURAFLEX(TM) BIOPROSTHESIS, MODELS 6625-LP AND 6625 ESR-LP
Classification Namereplacement heart-valve
Generic Nameheart valve for mitral valve replacement
Regulation Number870.3925
ApplicantBAXTER HEALTHCARE CORP.
PMA NumberP870077
Supplement NumberS003
Date Received04/17/1996
Decision Date10/17/1996
Product Code
DYE[ Registered Establishments with DYE ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Modification of your sterilization process to remove an aseptic sterilant-to-storage transfer process and replace it with a terminal steerilization process.
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