|Trade Name||RESTORE RECHARGEABLE NEUROSTIMULATION SYSTEM|
|Classification Name||stimulator, spinal-cord, totally implanted for pain relief|
|Generic Name||implantable programmable neurological electrical pulse generator|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the restore rechargeable neurostimulation system which 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.