Vercise Genus P16 Implantable PULSE GENERATOR KIT - Brain electrical stimulation system, antitremor - ARTG 400410
Access comprehensive regulatory information for Vercise Genus P16 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 registered under ARTG number 400410 and 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.
The Vercise Genus DBS System is indicated for use in the following: 路 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. 路 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. 路 Thalamic stimulation for the suppression of tremor not adequately controlled by medications in patients diagnosed with Essential Tremor or Parkinson's disease