Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Basic Information
- Device Name
- Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
- Trade Name
- Master Intellis Spinal Cord Stimulation Systems
- PMA Number
- P840001
- Supplement Number
- S529
- 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 8, 2023
- Date Received
- September 9, 2022
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Approval for a manufacturing site located at Medline Industries/Centurion Medical Products Corporation (FEI: 3005846326) Tri-State de Mexico, S. de R.L. de C.V. Calzada Presidente Venustiano Carranza, No. 301 Desarrollo Industrial Colorado Mexicali, Baja California, 21397, MEXICO as an alternate facility for kitting and final packaging of the Medtronic Model 97725 Wireless External Neurostimulator (ENS). Addition of Medline Industries, LP. (FEI: 3015173212) Mexicali Directo Al Cliente S. De R.L. De C.V. Circuito Del Desierto #71-A Parque Industrial del Desierto Mexicali Baja California 21395 Mexico as an alternate facility for sterilization of the Medtronic Model 97725 Wireless External Neurostimulator (ENS). The Model 97725 ENS shall be sterile packaged in an ISO certified controlled environment area (CEA) - ISO 14644-1 [class 8] or better.
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 |