Riik: Austraalia
keel: inglise
Allikas: Department of Health (Therapeutic Goods Administration)
Boston Scientific Pty Ltd
Class III
Boston Scientific Neuromodulation Corporation 25155 Rye Canyon Loop, Valencia, CA, 91355 United States Of America
37307 - Brain electrical stimulation system, antitremor
The Vercise PC System includes an External Trial Stimulator which is used to conduct intraoperative stimulation testing prior to implantation of the deep brain stimulator. The Vercise? PC System is an implantable Deep Brain Stimulator (DBS) system 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. This device is used for the temporary trial phase.
A
2016-08-15