PMA P030017S387

Device: Precision Spinal Cord Stimulator (SCS) Systems Introducer Hub Mold Change
Applicant: Boston Scientific Corp
PMA number: P030017
Supplement: S387
Product code: LGW
Decision date: 2026-02-11
Classification: Neurology
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: approval for a new Hub mold, with slight changes to the exiting parameters, used to overmold the dilator hub portion of the Introducer.

Current openFDA PMA Record#

Device: Precision Spinal Cord Stimulator (SCS) Systems Introducer Hub Mold Change
Applicant: Boston Scientific Corp
PMA number: P030017
Supplement: S387
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2026-02-11
Decision code: APPR
Date received: 2025-08-29
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for a new Hub mold, with slight changes to the exiting parameters, used to overmold the dilator hub portion of the Introducer.