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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceCARPENTIER-EDWARDS BIOPROSTHESES MODELS 2625&6625
Generic Namereplacement Heart-valve
Regulation Number870.3925
ApplicantEDWARDS LIFESCIENCES, LLC.
One Edwards Way
Irvine, CA 92614
PMA NumberP870056
Date Received09/24/1987
Decision Date09/25/1991
Withdrawal Date 01/28/2022
Product Code DYE 
Docket Number 91M-0395
Notice Date 11/12/1991
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Carpentier-Edwards® Bioprosthesis, Models 2625 (aortic) and 6625 (mitral). This device is intended for use in patients whose aortic or mitral valvular disease is sufficiently advanced to warrant replacement of their natural valve with a prosthetic one. It is also intended for use in patients with a previously implanted aortic or mitral valve prosthesis which is no longer functioning adequately and requires replacement.
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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