- Device
- Precision Spectra SCS Systems; Precision Novi SCS Systems; Precision Montage MRI SCS Systems; Spectra Wave Writer SCS Sy
- Applicant
- Boston Scientific Corp
- PMA number
- P030017
- Supplement
- S399
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2026-09-22
- Decision code
- APPR
- Date received
- 2026-07-16
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for an alternate battery for the Charger devices SC-5312 and NM-5312 which are used with the Boston Scientific Spinal Cord Stimulation (SCS) systems and Deep Brain Stimulation (DBS) systems, respectively.