Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Basic Information
- Device Name
- Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
- Trade Name
- MODEL 7421 ITREL(R) 7424 ITREL(R) II, 7425 ITREL(R) III AND MODEL 7427 SYNERGY(TM) IMPLANTABLE PULSE GENERATORS
- PMA Number
- P840001
- Supplement Number
- S052
- 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
- August 3, 2001
- Date Received
- April 10, 2001
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A CHANGE IN THE INDICATIONS FOR USE FROM "CHRONIC INTRACTABLE PAIN OF THE TRUNK OR LIMBS" TO "CHRONIC INTRACTABLE PAIN OF THE TRUNK AND/OR LIMBS". THE INDICATION STATEMENT HAS BEEN REVISED TO STATE "THE MEDTRONIC [TRADE NAME] SYSTEM IS INDICATED 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: FAILED BACK SYNDROME OR LOW BACK SYNDROME OR FAILED BACK, RADICULAR PAIN SYNDROME OR RADICULOPATHIES RESULTING IN PAIN SECONDARY TO FAILED BACK SYNDROME OR HERNIATED DISC, POST-LAMINECTOMY PAIN, MULTIPLE BACK OPERATIONS, UNSUCCESSFUL DISC SURGERY, DEGENERATIVE DISC DISEASE (DDD)/HERNIATED DISC PAIN REFRACTORY TO CONSERVATIVE AND SURGICAL INTERVENTIONS, PERIPHERAL CAUSALGIA, EPIDURAL FIBROSIS, ARACHNOIDITIS OR LUMBAR ADHESIVE ARACHNOIDITIS, COMPLEX REGIONAL PAIN SYNDROME (CRPS) OR 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 |