8 Contact Extension Kit - Electrode/lead, stimulator, implantable, neurological

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

MAH:

Boston Scientific Pty Ltd

class:

Class III

manufactured_by:

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

therapeutic_area:

44040 - Neural-tissue electrical stimulation lead

therapeutic_indication:

The 8 Contact Extension Kit is used to connect the DBS lead implanted in the skull to the Vercise IPG implanted under the clavicle. For use in: Unilateral or bilateral stimulation of the subthalamic nucleus (STN) or internal globus pallidus (GPi) for treatment of levodopa-responsive Parkinson's disease which is not adequately controlled with medication; Unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) for treatment of 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. The 8 Contact Extension Kit includes a DBS Extension, torque wrench, tunneling tool shaft & tunneling tool handle.

authorization_status:

A

authorization_date:

2012-10-18