Saluda Medical Evoke SCS System
FDA premarket approval P190002/S041 · decided 2025-08-21
Approval details
- PMA number
- P190002
- Supplement
- S041
- 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
- 2025-05-23
- Decision date
- 2025-08-21
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Atarmon
- Statement
- Approval for the addition of a Battery Pack Cup/Spacer to the Evoke Charger at the currently approved manufacturing site Integer-CCC (Montevideo, UY).
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