Saluda Medical Evoke SCS System
FDA premarket approval P190002/S034 · decided 2025-01-14
Approval details
- PMA number
- P190002
- Supplement
- S034
- Supplement type
- 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
- 2024-12-16
- Decision date
- 2025-01-14
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Atarmon
- Statement
- to update the bioburden alert and action limits to align with historical data for the Evoke CAP12 Percutaneous Lead and Trial Lead Kits, Evoke Spares Kit, Evoke Active Anchor Kit, Evoke Active Anchor Kit L, Evoke CAP12X Lead Extension Kit 55cm, Evoke Intraoperative Cable, Evoke Epidural Needle and Evoke Tunneler
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