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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.
Classification Nameimplant, cochlear
Generic Namecochlear implant
PMA NumberP970051
Date Received11/03/1997
Decision Date06/25/1998
Product Code
MCM[ Registered Establishments with MCM ]
Docket Number 98M-0711
Notice Date 09/09/1998
Advisory Committee Ear Nose & Throat
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Intended to restore a level of auditory sensationto adults and children via electrical stimulation of the auditory nerve.
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
S019 S020 S021 S022 S023 S024 S025 S026 S027 
S028 S029 S030 S031 S034 S035 S036 S037 S038 
S039 S041 S042 S043 S044 S045 S046 S047 S048 
S049 S050 S051 S052 S053 S054 S055 S057 S058 
S059 S060 S062 S063 S064 S065 S067 S068 S069 
S070 S071 S073 S074 S075 S076 S077 S078 S080 
S082 S085 S086 S087 S088 S089 S091 S092 S093 
S094 S095 S096 S097 S098 S100 S101 S103 S104 
S105 S106 S107 S108 S109 S110 S111 S112 S113 
S114 S115 S118 S119 S120 S121 S122 S123 S124 
S125 S126 S127 S128 S129 S131 S134