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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 DUAL 4-CHANNEL IMPLANTABLE PULSE GENERATOR (IPG)
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Generic Nameimplantable pulse generator system
ApplicantADVANCED NEUROMODULATION SYSTEM,INC
PMA NumberP010032
Supplement NumberS016
Date Received03/08/2005
Decision Date05/05/2005
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 genesis dual 4-channel implantable pulse generator (ipg), model 3643 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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