Saluda Medical Evoke SCS System
FDA premarket approval P190002/S037 · decided 2025-05-27
Approval details
- PMA number
- P190002
- Supplement
- S037
- 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
- 2025-02-28
- Decision date
- 2025-05-27
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Atarmon
- Statement
- Approval for updating the Printed Circuit Board Assembly (PCBA) of the Evoke Charger by replacing 2 transistors and an electromagnetic interference (EMI) Filter with functionally equivalent alternate components due to obsolescence
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