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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 BIOPROSTHESIS MODELS 6625LP AND 6625 LP-ESR
Classification Namereplacement heart-valve
Generic Nameheart valve for mitral valve replacement
Regulation Number870.3925
ApplicantBAXTER HEALTHCARE CORP.
PMA NumberP870077
Supplement NumberS008
Date Received10/09/1998
Decision Date10/26/1998
Product Code
DYE[ Registered Establishments with DYE ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The 30-day notice requested a change in the incubation period for the test of sterility (of both the sterilant solution and of sterilized products) to reduce the total time required to manufacture the bioprostheses.
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