- Device
- Precision Spinal Cord Stimulator (SCS) Systems
- Applicant
- Boston Scientific Corp
- PMA number
- P030017
- Supplement
- S398
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2026-08-10
- Decision code
- OK30
- Date received
- 2026-07-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to update the laser excise process settings used in spinal cord stimulation and deep brain stimulation implantable pulse generators at the Clonmel facility