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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
DeviceGENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Generic Namestimulator, spinal-cord, totally implanted for pain relief
Applicant
St. Jude Medical
6901 preston road
plano, TX 75024
PMA NumberP010032
Date Received05/29/2001
Decision Date11/21/2001
Product Code
LGW[ Registered Establishments with LGW ]
Docket Number 01M-0534
Notice Date 12/03/2001
Advisory Committee Neurology
Expedited Review Granted? No
Combination Product 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: 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 S126 
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