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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameCARPENTIER-EDWARDS BIOPROSTHESES MODELS 2625&6625
Classification Namereplacement heart-valve
Generic Nameheart valve bioprosthesis
Regulation Number870.3925
ApplicantEDWARDS LIFESCIENCES, LLC.
PMA NumberP870056
Date Received09/24/1987
Decision Date09/25/1991
Product Code
DYE[ Registered Establishments with DYE ]
Docket Number 91M-0395
Notice Date 11/12/1991
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Supplements: S002 S003 S006 S010 S011 S012 S013 S014 S015 
S016 S017 S018 S019 S020 S021 S022 S023 S024 
S025 S027 S028 S029 S030 S031 S032 S033 S034 
S035 S036 S037 S038 S039 S040 S041 S042 S043 
S044 S045 S046 S047 S048 S049 S050 S051 S052 
S053 S054 S055 S056 S057 S058 S059 S060 S061 
S062 S063 S064 S065 S066 S067 
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