Saluda Medical Evoke SCS System
FDA premarket approval P190002/S028 · decided 2024-10-31
Approval details
- PMA number
- P190002
- Supplement
- S028
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Saluda Medical Evoke SCS System
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Saluda Medical Pty, Ltd.
- Date received
- 2024-04-19
- Decision date
- 2024-10-31
- Days to decision
- 195 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Atarmon
- Statement
- a manufacturing process change from manual skiving to laser ablation to remove material from the multilumen component of percutaneous leads manufactured at Heraeus Medevio (formerly Heraeus Medical Components)
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