PMA P190002S007
- Device
- Saluda Medical Evoke® SCS System
- Applicant
- Saluda Medical Pty, Ltd.
- Product code
- LGW
- Decision date
- 2022-07-14
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Approval for design changes to the Evoke® SCS System, lead (including the trial lead) and stylet components.
Current openFDA PMA Record#
- Device
- Saluda Medical Evoke® SCS System
- Applicant
- Saluda Medical Pty, Ltd.
- PMA number
- P190002
- Supplement
- S007
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2022-07-14
- Decision code
- APPR
- Date received
- 2022-04-15
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for design changes to the Evoke® SCS System, lead (including the trial lead) and stylet components.