|
Device | RESTORE RECHARGEABLE NEUROSTIMULATION SYSTEM |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | MEDTRONIC NEUROMODULATION 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432 |
PMA Number | P840001 |
Supplement Number | S074 |
Date Received | 10/12/2004 |
Decision Date | 04/08/2005 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
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. |