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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, GENESIS RC, GENESIS XP AND THE EON NEUROSTIMULATION SYSTEMS
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Generic Nameimplantable pulse generator system
ApplicantADVANCED NEUROMODULATION SYSTEM,INC
PMA NumberP010032
Supplement NumberS020
Date Received03/26/2007
Decision Date06/11/2007
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of the tripole 8, tripole 8c, tripole 16c, and exclaim 8 lamitrode series leads (models 3208, 3210, 3214, 3224) with the genesis, genesis rc, genesis xp, and eon neurostimulation systems, which are 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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