PMA P030017S391

Device: Precision Spinal Cord Stimulator (SCS) Systems
Applicant: Boston Scientific Corp
PMA number: P030017
Supplement: S391
Product code: LGW
Decision date: 2026-01-22
Classification: Neurology
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: approval for an alternate sterilization facility and to transfer final packaging and distribution activities to another facility

Current openFDA PMA Record#

Device: Precision Spinal Cord Stimulator (SCS) Systems
Applicant: Boston Scientific Corp
PMA number: P030017
Supplement: S391
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2026-01-22
Decision code: OK30
Date received: 2025-12-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for an alternate sterilization facility and to transfer final packaging and distribution activities to another facility