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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 Namestimulator, spinal-cord, totally implanted for pain relief
7000 central avenue ne
minneapolis, MN 55432
PMA NumberP840001
Supplement NumberS097
Date Received05/18/2007
Decision Date01/08/2008
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the restoreultra rechargeable neurostimulation system. The device is indicated as an aid in the management of chronic, intractable, unilateral or bilateral pain associated with the following: 1) failed back syndrome or low back syndrome or failed back; 2) radicular pain syndrome or radiculopathies resulting in pain secondary to failed back syndrome; 3) post laminectomy pain; 4) unsuccessful disk surgery; 5) degenerative disk disease (ddd)/herniated disk pain refractory to conservative and surgical interventions; 6) peripheral causalgia; 7) epidural fibrosis; 8) arachnoiditis or lumbar adhesive arachnoiditis; 9) complex regional pain syndrome (crps) or reflex sympathetic dystrophy (rsd) or causalgia; and 10) multiple back surgeries.