PMA P150031S083

Device: Vercise Genus, Vercise Gevia, Vercise PC, Vercise DBS Systems
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S083
Product code: NHL
Decision date: 2025-05-20
Classification: Neurology
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
Approval order statement: The thickness of the Slider of the Burr Hole Cover Kit, which is used to secure DBS leads, is requested to be reduced from 0.030” to 0.025

Current openFDA PMA Record#

Device: Vercise Genus, Vercise Gevia, Vercise PC, Vercise DBS Systems
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S083
Product code: NHL
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
Decision date: 2025-05-20
Decision code: APPR
Date received: 2025-02-21
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: The thickness of the Slider of the Burr Hole Cover Kit, which is used to secure DBS leads, is requested to be reduced from 0.030” to 0.025