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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 DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS
Generic Namereplacement Heart-valve
Regulation Number870.3925
ApplicantEDWARDS LIFESCIENCES, LLC.
One Edwards Way
Irvine, CA 92614
PMA NumberP870077
Date Received12/07/1987
Decision Date09/25/1991
Withdrawal Date 01/28/2022
Product Code DYE 
Docket Number 91M-0410
Notice Date 11/12/1991
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Carpentier-Edwards® Duraflex™ Bioprosthesis, Models 6625 LP and 6625-ESR-LP. These devices are intended for use in patients whose 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 mitral valve prosthesis which is no longer functioning adequately and requires replacement.
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S008 S009 S010 S011 S012 S013 S014 S015 
S016 S017 S018 S019 S020 S021 S022 S023 S025 S026 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 
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