Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | RESTORESENSOR RECHARGABLE IMPLANTABLE 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 | S185 |
Date Received | 05/16/2011 |
Decision Date | 11/03/2011 |
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 |
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. |
|
|