Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Basic Information
- Device Name
- Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
- Trade Name
- ITREL 4 IMPLANTABLE NEUROSTIMULATION SYSTEM
- PMA Number
- P840001
- Supplement Number
- S211
- 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
- May 30, 2012
- Date Received
- April 5, 2012
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR ITREL 4 NEUROSTIMULATORS, MODELS 37703 AND 37704. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES ITREL 4 NEUROSTIMULATORS, MODELS 37703 AND 37704 AND ARE INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC, INTRACTABLE PAIN OFTHE 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;7) PERIPHERAL CAUSALGIA; 8) EPIDURAL FIBROSIS; 9) ARACHNOIDITIS OR LUMBAR ADHESIVE ARACHNOIDITIS; 10) COMPLEX REGIONAL PAIN SYNDROME (CRPS);11) REFLEX SYMPATHETIC DYSTROPHY (RSD), OR 11) 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 |