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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.
 
DeviceNUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Generic Nameimplant, cochlear
Applicant
Cochlear Americas
13059 east peakview avenue
centennial, CO 80111
PMA NumberP970051
Date Received11/03/1997
Decision Date06/25/1998
Product Code 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.
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 S116 S118 S119 S120 S121 S122 
S123 S124 S125 S126 S127 S128 S129 S130 S131 
S132 S133 S134 S135 S136 S137 S138 S139 S140 
S141 S142 S143 S144 S145 S146 S147 S148 S149 
S150 S151 S153 S154 S155 S156 S157 S158 S159 
S160 S161 S162 S163 S164 S165 S166 S167 S168 
S169 S170 S171 S172 S173 S174 S175 S176 S177 
S178 S179 S180 S181 S182 S183 S184 S185 S186 
S187 S188 S189 S191 S192 S193 S194 S195 S196 
S197 S198 S199 
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