- Device
- Saluda Medical Evoke® SCS System
- Applicant
- Saluda Medical Pty, Ltd.
- PMA number
- P190002
- Supplement
- S004
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2022-04-20
- Decision code
- OK30
- Date received
- 2022-03-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a new component manufacturer (Heraeus Medical Components LLC) for the Evoke SCS System Stylets (60/90 cm Bent and Straight).