PMA P150031S098

Device: Vercise Genus DBS Systems; Vercise Gevia DBS Systems
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S098
Product code: NHL
Decision date: 2026-09-22
Classification: Neurology
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
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.

Current openFDA PMA Record#

Device: Vercise Genus DBS Systems; Vercise Gevia DBS Systems
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S098
Product code: NHL
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
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.