Saluda Medical Evoke® SCS System
FDA premarket approval P190002/S015 · decided 2022-12-29
Approval details
- PMA number
- P190002
- Supplement
- S015
- 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
- 2022-09-30
- Decision date
- 2022-12-29
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Atarmon
- Statement
- Approval for software and firmware changes to the Clinical Programming Application (CPA) and Clinical Data Viewer (CDV) intended to simplify the clinical software, improve usability and user interface during programming, and improve traceability. Labeling changes were also proposed to modify the instructions for use based on the software and firmware changes.
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