|Trade Name||RESTORESENSOR RECHARGABLE IMPLANTABLE NEUROSTIMULATION SYSTEM|
|Classification Name||stimulator, spinal-cord, totally implanted for pain relief|
|Generic Name||stimulator, spinal-cord, totally implanted for pain relief|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the restoresensor rechargeable implantable neurostimulation system. The device, as modified, will be marketed under the trade name restoresensor rechargeable implantable neurostimulation system and is indicated for spinal cord stimulation (scs) as an aid in the management of chronic, intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following conditions:1) failed back syndrome (fbs) or low back syndrome or failed back; 2) radicular pain syndrome or radiculopathies resulting in pain secondary to fbs or herniated disk; 3) postlaminectomy pain; 4) multiple back operations; 5) unsuccessful disk surgery; 6) degenerative disk disease (ddd)/herniated disk pain refractory to conservative and surgical interventions; 5) peripheral causalgia; 6) epidural fibrosis; 7) arachnoiditis or lumbar adhesive arachnoiditis; and 8) complex regional pain syndrome (crps), reflex sympathetic dystrophy (rsd), or causalgia.