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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 NumberS009
Date Received11/17/2003
Decision Date01/20/2004
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 axxess percutaneous lead models 4143, 4146, 4153 and 4156 with the ans genesis neurostimulation (ipg) model 3608, the ans genesis xp neurostimulation (ipg) model 3609, the ans genesis dual xp neurostimulation (ipg) model 3644 and the ans genesis g4 neurostimulation (ipg) model 3604 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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