Premarket Approval (PMA)

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.

• Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Generic Name: Implant, cochlear
• Applicant: Cochlear Americas; 10350 Park Meadows Drive; Lone Tree, CO 80124
• PMA Number: P970051
• Date Received: 11/03/1997
• Decision Date: 06/25/1998
• 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: S107 S108 S109 S119 S120 S065 S067 S068 S069 S070 S071 ; S073 S074 S075 S076 S077 S078 S080 S082 S085 S086 S087 S135 ; S136 S137 S100 S101 S127 S122 S130 S131 S091 S092 S093 S094 ; S095 S052 S030 S031 S025 S026 S027 S014 S015 S016 S035 S036 ; S012 S013 S020 S021 S022 S041 S042 S043 S044 S009 S010 S007 ; S008 S050 S051 S049 S063 S064 S039 S004 S005 S006 S034 S139 ; S140 S141 S142 S149 S155 S159 S160 S001 S002 S003 S011 S088 ; S112 S113 S114 S115 S116 S123 S132 S103 S104 S105 S128 S096 ; S097 S121 S138 S089 S124 S125 S126 S133 S134 S110 S118 S098 ; S129 S106 S111 S023 S024 S037 S038 S017 S018 S019 S028 S029 ; S046 S047 S053 S054 S055 S057 S058 S059 S045 S060 S062 S143 ; S144 S145 S150 S151 S161 S162 S163 S166 S167 S146 S147 S148 ; S156 S157 S158 S153 S154 S048 S173 S180 S164 S165 S177 S193 ; S194 S186 S187 S196 S197 S214 S207 S218 S219 S170 S178 S179 ; S181 S174 S175 S176 S171 S172 S168 S169 S188 S189 S200 S185 ; S183 S184 S195 S198 S203 S190 S191 S192 S182 S199 S212 S215 ; S216 S217 S221 S222 S201 S202 S205 S206 S204 S213 S208 S209 ; S210 S211 S223 S224