8 Contact Extension Kit - Electrode/lead, stimulator, implantable, neurological
देश: ऑस्ट्रेलिया
भाषा: अंग्रेज़ी
स्रोत: Department of Health (Therapeutic Goods Administration)
सार्वजनिक आकलन रिपोर्ट
(PAR)
12-11-2017
अनुरोध भेजा।
थमां उपलब्ध:
Boston Scientific Pty Ltd
वर्ग:
Class III
द्वारा बनाया गया:
Boston Scientific Neuromodulation Corporation 25155 Rye Canyon Loop, Valencia, CA, 91355 United States Of America
चिकित्सीय क्षेत्र:
44040 - Neural-tissue electrical stimulation lead
चिकित्सीय संकेत:
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.
प्राधिकरण का दर्जा:
A
प्राधिकरण की तारीख:
2012-10-18
