- Device
- Saluda Medical Evoke SCS System
- Applicant
- Saluda Medical Pty, Ltd.
- PMA number
- P190002
- Supplement
- S036
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2026-01-06
- Decision code
- APPR
- Date received
- 2025-01-27
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for a manufacturing site located at Greatbatch Medical S. De R.L. De C.V., Calle 5 Norte No. 511 Ciudad, Industrial, Tijuana, Baja California, MX 22444, FEI: 3011823740 to manufacturer the Evoke Charger