PMA P190002S051
- Device
- Saluda Medical Evoke SCS System
- Applicant
- Saluda Medical Pty, Ltd.
- PMA number
- P190002
- Supplement
- S051
- Product code
- LGW
- Decision date
- 2026-10-15
- Classification
- Neurology
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- change the formulation of the adhesive used on the Tyvek packaging of the paddle lead kit
Current openFDA PMA Record#
- Device
- Saluda Medical Evoke SCS System
- Applicant
- Saluda Medical Pty, Ltd.
- PMA number
- P190002
- Supplement
- S051
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2026-10-15
- Decision code
- OK30
- Date received
- 2026-09-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- change the formulation of the adhesive used on the Tyvek packaging of the paddle lead kit