PMA P150031S066

Device: Vercise Genus Deep Brain Stimulation (DBS) System
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S066
Product code: NHL
Decision date: 2024-01-10
Classification: Neurology
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
Approval order statement: approval for MR Conditional status of the following three configurations for use with two Boston Scientific Vercise Genus Implanted Pulse Generators (IPG): Boston Scientific Leads, One IPG with Boston Scientific Lead and One IPG with Medtronic Lead (with M8 Lead Adapter), and Medtronic Leads (with M8 Lead Adapters)

Current openFDA PMA Record#

Device: Vercise Genus Deep Brain Stimulation (DBS) System
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S066
Product code: NHL
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
Decision date: 2024-01-10
Decision code: APPR
Date received: 2023-10-26
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for MR Conditional status of the following three configurations for use with two Boston Scientific Vercise Genus Implanted Pulse Generators (IPG): Boston Scientific Leads, One IPG with Boston Scientific Lead and One IPG with Medtronic Lead (with M8 Lead Adapter), and Medtronic Leads (with M8 Lead Adapters)