- Device
- Saluda Medical Evoke® SCS System
- Applicant
- Saluda Medical Pty, Ltd.
- PMA number
- P190002
- Supplement
- S015
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2022-12-29
- Decision code
- APPR
- Date received
- 2022-09-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.