Saluda Medical Evoke® SCS System
FDA premarket approval P190002/S030 · decided 2024-10-10
Approval details
- PMA number
- P190002
- Supplement
- S030
- 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
- 2024-09-09
- Decision date
- 2024-10-10
- Days to decision
- 31 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Atarmon
- Statement
- to upgrade the blister tray sealer equipment from a single to a double blister tray sealer (two separate Implantable Pulse Generator kits may be sealed at the same time) and to change the temperature, time, and pressure sealing parameters to accommodate the new equipment
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