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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.
 
DeviceGENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantAbbott Medical
6901 Preston Road
Plano, TX 75024
PMA NumberP010032
Date Received05/29/2001
Decision Date11/21/2001
Product Code LGW 
Docket Number 01M-0534
Notice Date 12/03/2001
Advisory Committee Neurology
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH 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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements: S040 S041 S043  S071 S083 S037 S038 S039 S084 S074 S075 
S076 S070 S049 S102 S103 S104 S105 S106 S107 S093 S094 S095 
S064 S080 S057 S058 S059 S060 S061 S062 S048 S031 S032 S013 
S014 S016 S009 S018 S019 S002 S003 S021 S022 S029 S028 S034 
S035 S036 S008 S110 S111 S112 S117 S122 S044 S085 S097 S065 
S066 S067 S068 S081 S082 S108 S109 S050 S051 S052 S053 S054 
S055 S056 S045 S047 S086 S087 S088 S089 S090 S091 S092 S098 
S099 S100 S101 S072 S077 S078 S079 S063 S096 S073 S005 S006 
S007 S017 S010 S011 S012 S024 S025 S020 S023 S026 S113 S124 
S125 S114 S115 S116 S130 S118 S119 S120 S126 S127 S128 S129 
S027 S136 S137 S138 S150 S151 S160 S161 S162 S163 S164 S149 
S168 S156 S145 S173 S174 S187 S180 S181 S182 S183 S170 S196 
S197 S198 S203 S204 S205 S206 S132 S133 S141 S139 S140 S134 
S135 S143 S146 S147 S165 S148 S155 S157 S158 S159 S152 S153 
S154 S144 S166 S167 S190 S191 S192 S193 S194 S184 S176 S177 
S199 S195 S172 S188 S189 S175 S169 S185 S186 S178 S179 S209 
S214 S210 S212 S200 S201 S202 S207 
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