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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 NameEDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES
Classification Namereplacement heart-valve
Generic Namebioprosthetic heart valve
Regulation Number870.3925
ApplicantEDWARDS LIFESCIENCES, LLC.
PMA NumberP860057
Date Received11/18/1986
Decision Date09/26/1991
Product Code
DYE[ Registered Establishments with DYE ]
Docket Number 91M-0397
Notice Date 11/12/1991
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product Yes
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S003 S004 S006 S009 S010 S011 S012 S013 
S014 S015 S016 S017 S018 S019 S020 S021 S022 
S023 S024 S025 S026 S027 S028 S029 S030 S031 
S032 S033 S034 S035 S036 S037 S038 S039 S040 
S041 S042 S044 S045 S046 S047 S048 S050 S051 
S052 S053 S054 S055 S056 S057 S058 S059 S060 
S061 S062 S063 S064 S065 S066 S067 S068 S069 
S070 S071 S072 S073 S074 S075 S076 S078 S079 
S081 S082 S083 S085 S086 S087 S088 S089 S090 
S091 S092 S093 S094 S095 S096 S097 S098 S099 
S100 S101 S102 S103 S104 S105 S106 S107 S108 
S109 S110 S111 S112 S113 S114 S115 S116 S117 
S118 S119 S120 S121 S122 S123 S124 S125 S126 
S128 
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