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: GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS
• Generic Name: Stimulator, spinal-cord, totally implanted for pain relief
• Applicant: ABBOTT MEDICAL; 6901 Preston Rd.; Plano, TX 75024
• PMA Number: P010032
• Date Received: 05/29/2001
• Decision Date: 11/21/2001
• Product Code: LGW
• Docket Number: 01M-0534
• Notice Date: 12/03/2001
• Advisory Committee: Neurology
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No
• Recalls: CDRH Recalls

Approval Order Statement  
APPROVAL FOR THE GENESIS NEUROSTIMULATION (IPG) SYSTEM. THE SYSTEM INCLUDES THE FOLLOWING COMPONENTS: THE MODEL 3608 PULSE GENERATOR, THE MODEL 3850 PATIENT PROGRAMMER, THE MODEL 1232 PROGRAMMING WAND AND THE MODEL 1210 PATIENT MAGNET. THE DEVICE IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC INTRACTABLE PAIN OF THE TRUNK AND/OR LIMBS, INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2
• Supplements: S006 S007 S008 S009 S010 S011 S012 S013 S014 S016 S017 S018 ; S019 S020 S021 S022 S023 S024 S025 S026 S027 S028 S029 S031 ; S032 S034 S035 S036 S037 S038 S039 S040 S041 S043 S044 S045 ; S047 S048 S049 S050 S051 S052 S053 S054 S055 S056 S057 S058 ; S059 S060 S061 S062 S063 S064 S065 S066 S067 S068 S070 S071 ; S072 S073 S074 S075 S076 S077 S078 S079 S080 S081 S082 S083 ; S084 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 S122 S124 S125 S126 S127 S128 S129 S130 S132 S133 S134 ; S135 S136 S137 S138 S139 S140 S141 S143 S144 S145 S146 S147 ; S148 S149 S150 S151 S152 S153 S154 S155 S156 S157 S158 S159 ; S160 S161 S162 S163 S164 S165 S166 S167 S168 S169 S170 S172 ; S173 S174 S175 S176 S177 S178 S179 S180 S181 S182 S183 S184 ; S185 S186 S187 S188 S189 S190 S191 S192 S193 S194 S195 S196 ; S197 S198 S199 S200 S201 S202 S203 S204 S205 S206 S207 S209 ; S210 S211 S212 S213 S214 S215 S216 S217 S218 S219 S220 S221 ; S222 S223 S224 S225 S226 S227 S228 S229 S230 S231 S232 S233 ; S234 S235 S236 S237 S238 S239 S240 S241 S242 S243 S244 S245 ; S246 S247 S248 S249 S250 S252 S253 S254 S255 S259 S261 ; S002 S003 S005