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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.
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Generic Nameimplantable pulse generator system
PMA NumberP010032
Supplement NumberS021
Date Received07/13/2007
Decision Date12/10/2007
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of the ans eonc (ipg) neuromodulation system, model 3688 which is indicated as an aid in the management of chronic pain of the trunk and/or limb, including unilateral and bilateral pain associated with any of the following: failed back surgery syndrome, and intractable low back and leg pain.