Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Basic Information
- Device Name
- Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
- Trade Name
- RESTORESENSOR RECHARGABLE IMPLANTABLE NEUROSTIMULATION SYSTEM
- PMA Number
- P840001
- Supplement Number
- S185
- Device Class
- FDA Class 3
- Product Code
- LGW
- Generic Name
- Stimulator, spinal-cord, totally implanted for pain relief
- Medical Specialty
- Unknown
- Advisory Committee
- Neurology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- November 3, 2011
- Date Received
- May 16, 2011
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LGW | Stimulator, Spinal-Cord, Totally Implanted For Pain Relief | FDA class 3 | Unknown |