Australia TGA ARTG record

Vercise Genus R32 Implantable PULSE GENERATOR KIT - Brain electrical stimulation system, antitremor

Australia TGA ARTG Registered Device · Boston Scientific Pty Ltd · Boston Scientific Neuromodulation Corporation · Class III · Started December 01, 2022

Good Name: Boston Scientific Pty Ltd - Vercise Genus R32 Implantable PULSE GENERATOR KIT - Brain electrical stimulation system, antitremor

Device classification

Risk Class: Class III
Product Type: Medical device system
ARTG Category: General

Registration information

Start Date: December 01, 2022
Effective Date: December 01, 2022

Sponsor

Name: Boston Scientific Pty Ltd

Manufacturer

Name: Boston Scientific Neuromodulation Corporation
Country: United States of America
Address: 25155 Rye Canyon Loop, Valencia, CA, 91355

Intended purpose

The Vercise Genus DBS System is indicated for use in the following: · Unilateral or bilateral stimulation of the subthalamic nucleus (STN) or internal globus pallidus (GPi) for levodopa-responsive Parkinson's disease which is not adequately controlled with medication. · Unilateral or bilateral stimulation of the subthalamic nucleus (STN) or internal globus pallidus (GPi) for intractable primary and secondary dystonia, for persons 7 years of age and older. · Thalamic stimulation for the suppression of tremor not adequately controlled by medications in patients diagnosed with Essential Tremor or Parkinson's disease

About this record

Access comprehensive regulatory information for Vercise Genus R32 Implantable PULSE GENERATOR KIT - Brain electrical stimulation system, antitremor in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Boston Scientific Pty Ltd, manufactured by Boston Scientific Neuromodulation Corporation in United States of America. The device registration started on December 01, 2022.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.