- Device
- Precision Spinal Cord Stimulator (SCS) Systems
- Applicant
- Boston Scientific Corp
- PMA number
- P030017
- Supplement
- S394
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2026-05-13
- Decision code
- OK30
- Date received
- 2026-04-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to utilize an alternate vapor degreasing solvent during the initial cleaning process for non-patient contacting machined metal components by a supplier