Saluda Medical Evoke® SCS System
FDA premarket approval P190002/S013 · decided 2022-12-15
Approval details
- PMA number
- P190002
- Supplement
- S013
- 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
- 2022-09-19
- Decision date
- 2022-12-15
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Atarmon
- Statement
- Approval for design changes to the set screw and set screw block components of the lead extension, including an increase in set screw block inner diameter, increase in thread size of the set screw and set screw block hole, and other minor changes in geometry.
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