Saluda Medical Evoke® SCS System
FDA premarket approval P190002/S045 · decided 2025-11-08
Approval details
- PMA number
- P190002
- Supplement
- S045
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Saluda Medical Evoke® SCS System
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Saluda Medical Pty, Ltd.
- Date received
- 2025-08-11
- Decision date
- 2025-11-08
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Atarmon
- Statement
- Approval for replacement of components on the Evoke Patient Controller (EPC) Printed Circuit Board Assembly (PCBA) due to obsolescence.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.