PMA P030017S377

Device: Precision Spinal Cord Stimulator (SCS) Systems
Applicant: Boston Scientific Corp
PMA number: P030017
Supplement: S377
Product code: LGW
Decision date: 2026-01-21
Classification: Neurology
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Approval for the following changes related to the OR cables and extensions: 1) an alternate manufacturing site (i.e., Jiangyin SINBON Electronics Co. Ltd., FDA Establishment Identifier – 3007616088), 2) dimensional changes, 3) change of material for two polyurethane components (i.e., strain relief and cable jacket) to a trademarked thermoplastic polyurethane (i.e., IROGRAN A75E 5040), and 4) removal of a duplicative cleaning step.

Current openFDA PMA Record#

Device: Precision Spinal Cord Stimulator (SCS) Systems
Applicant: Boston Scientific Corp
PMA number: P030017
Supplement: S377
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2026-01-21
Decision code: APPR
Date received: 2024-07-29
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the following changes related to the OR cables and extensions: 1) an alternate manufacturing site (i.e., Jiangyin SINBON Electronics Co. Ltd., FDA Establishment Identifier – 3007616088), 2) dimensional changes, 3) change of material for two polyurethane components (i.e., strain relief and cable jacket) to a trademarked thermoplastic polyurethane (i.e., IROGRAN A75E 5040), and 4) removal of a duplicative cleaning step.