Vercise Genus R16 Implantable PULSE GENERATOR KIT - Brain electrical stimulation system, antitremor

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Osta kohe

Laadi alla Avaliku hindamisaruande (PAR)
20-07-2021

Saadav alates:

Boston Scientific Pty Ltd

Klass:

AIMD

Valmistatud:

Boston Scientific Neuromodulation Corporation 25155 Rye Canyon Loop, Valencia, CA, 91355 United States Of America

Terapeutiline ala:

37307 - Brain electrical stimulation system, antitremor

Näidustused:

The Vercise Genus System includes the Rechargeable Vercise Genus Implantable Pulse Generator (IPG, also known as the Vercise Genus Stimulator). The contents of the Vercise Genus Implantable Pulse Generator Kit are: ? Implantable Pulse Generator ? IPG Template ? Port Plug ? Hex Wrench 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.

Volitamisolek:

A

Loa andmise kuupäev:

2021-04-28

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