- Device
- Saluda Medical Evoke® SCS System
- Applicant
- Saluda Medical Pty, Ltd.
- PMA number
- P190002
- Supplement
- S002
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2022-04-06
- Decision code
- APPR
- Date received
- 2022-03-07
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for updated labeling to limit use of the lead extension to the trial procedure, rather than at permanent implantation