|Trade Name||RESTORE ADVANCED & PRIME ADVANCED NEUROSTIMULATIONS SYSTEMS|
|Classification Name||stimulator, spinal-cord, totally implanted for pain relief|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the restore advanced and prime advanced neurostimulation systems. The devices are 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.