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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameGENESIS NEUROSTIMULATION (IPG) SYSTEM
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Generic Nameimplantable pulse generator system
ApplicantADVANCED NEUROMODULATION SYSTEM,INC
PMA NumberP010032
Supplement NumberS008
Date Received06/06/2003
Decision Date08/22/2003
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of the model a127 lead extension (models 2341, 2342, 2343 and 2346) which 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.
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