Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Basic Information
- Device Name
- Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
- Trade Name
- PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM
- PMA Number
- P030017
- Supplement Number
- S134
- 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
- December 21, 2012
- Date Received
- May 7, 2012
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE PRECISION SPECTRA SYSTEM WHICH INCLUDES THE FOLLOWING COMPONENTS:1) MODEL SC-1132 PRECISION SPECTRA IMPLANTABLE PULSE GENERATOR (LPG); 2)MODEL SC-440 I PRECISION SPECTRA LPG PORT PLUG; 3) MODEL SC-5132 PRECISION SPECTRA EXTERNAL TRIAL STIMULATOR; 4) MODEL SC-6360-32 PRECISION SPECTRA PATIENT TRIAL BELT; 4) MODEL SC-6500-32 PATIENT TRIAL KIT; 5) MODEL SC-5232 PRECISION SPECTRA REMOTE CONTROL; 6) MODEL SC-5532-1 PRECISION SPECTRA REMOTE CONTROL KIT; 7) MODEL NM-631 0 AND NM-621 0 USB POWER SUPPLY; AND 8) MODEL NM-621 0 REMOTE CONTROL HOLSTER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PRECISION SPECTRA SYSTEM AND 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 SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN.
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 |