- Device
- Precision Spinal Cord Stimulator (SCS) Systems
- Applicant
- Boston Scientific Corp
- PMA number
- P030017
- Supplement
- S397
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2026-07-10
- Decision code
- OK30
- Date received
- 2026-06-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to add a new controlled environment area (CEA) which is a Class 8 cleanroom, at the Boston Scientific Dorado, Puerto Rico facility for the manufacture of Boston Scientific Neuromodulation (BSN) Spinal Cord Stimulator (SCS) and Deep Brain Stimulation (DBS) Products