PMA P150031S089

Device: Vercise Genus™ Deep Brain Stimulation (DBS) Systems
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S089
Product code: NHL
Decision date: 2025-12-10
Classification: Neurology
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
Approval order statement: approval for the extension of shelf-life from 6 months to 15 months for the Hydrogen Silsesquioxane material utilized in the insulation layer production of a component within the printed circuit board assembly of Implantable Pulse Generator (IPG) and of External Trial Stimulator (ETS) Kits in the WaveWriter Alpha™ Prime Spinal Cord Stimulation and Vercise™ Genus Deep Brain Stimulation Systems. The component, manufactured by a third-party supplier, is not patient-contacting and is fully encapsulated within the IPG and ETS.

Current openFDA PMA Record#

Device: Vercise Genus™ Deep Brain Stimulation (DBS) Systems
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S089
Product code: NHL
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
Decision date: 2025-12-10
Decision code: APPR
Date received: 2025-09-25
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for the extension of shelf-life from 6 months to 15 months for the Hydrogen Silsesquioxane material utilized in the insulation layer production of a component within the printed circuit board assembly of Implantable Pulse Generator (IPG) and of External Trial Stimulator (ETS) Kits in the WaveWriter Alpha™ Prime Spinal Cord Stimulation and Vercise™ Genus Deep Brain Stimulation Systems. The component, manufactured by a third-party supplier, is not patient-contacting and is fully encapsulated within the IPG and ETS.