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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:  S002 S003 S005 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 S188 
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