Australia - English - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 37307 - brain electrical stimulation system, antitremor - the neurostimulator is a quadripolar, multi-program device that delivers stimulation through one lead. the stimulation settings are stored in programs which are specific combinations of pulse width, rate and amplitude. the device is indicated for stimulation of the ventral intermediate nucleus for patients with disabling essential tremor or parkinsonian tremor, or stimulation of the internal globus pallidus or the subthalamic nucleus for patients with symptoms of parkinson's disease. studies have shown that deep brain stimulation with the medtronic dbs therapy system is effective in controlling essential tremor and symptoms of parkinson's disease that are not adequately controlled with medications. additionally, dbs is effective in controlling dyskinesias and fluctuations associated with medical therapy for parkinson's disease. medtronic dbs therapy for movement disorders is also indicated for stimulation of the internal globus pallidus or the subthalamic nucleus as an aid in the management of chronic, intrac

Australia - English - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 37307 - brain electrical stimulation system, antitremor - the neurostimulator is a octapolar, multi-program device that delivers stimulation through one lead. the stimulation settings are stored in programs which are specific combinations of pulse width, rate and amplitude. the device is indicated for stimulation of the ventral intermediate nucleus for patients with disabling essential tremor or parkinsonian tremor, or stimulation of the internal globus pallidus or the subthalamic nucleus for patients with symptoms of parkinson's disease. studies have shown that deep brain stimulation with the medtronic dbs therapy system is effective in controlling essential tremor and symptoms of parkinson's disease that are not adequately controlled with medications. additionally, dbs is effective in controlling dyskinesias and fluctuations associated with medical therapy for parkinson's disease. medtronic dbs therapy for movement disorders is also indicated for stimulation of the internal globus pallidus or the subthalamic nucleus as an aid in the management of chronic, intracta

Australia - English - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd -

Australia - English - Department of Health (Therapeutic Goods Administration)

boston scientific pty ltd - 47502 - image segmentation application software - guide dbs is intended to display medical images and simulate output. it includes functions for image manipulation and 3d visualization. features include display of a simulated dbs lead from a patient?s ct scan compared with an anatomical atlas. guide dbs system consists of a guide dbs station with a touch pad, mouse, keyboard, usb optical drive and flash drive.

Australia - English - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd -

Australia - English - Department of Health (Therapeutic Goods Administration)

boston scientific pty ltd - 44063 - surgical procedure kit, neurosurgical, single-use, non-medicated - the kit functions as a source of dbs lead kit components, should back-up items be needed during the procedure. the kit enables replacement of these small parts without the need to open a new lead kit. the kit contains suture sleeves, torque wrench, lead boot, lead stop set screw and lead stop ring.

Australia - English - Department of Health (Therapeutic Goods Administration)

elekta pty ltd - 32568 - stereotactic surgery system, neurological - the device incorporates three components: inner guide tube for electrode, outer guide tube for dbs lead and a mandrin. during insertion of the device all components are combined. the elekta/ inomed microdrive is used to position the device. after insertion the mandrin is removed and the electrode is inserted through the inner guide tube. after a successful mer the electrode and inner guide tube are removed. the dbs lead is inserted with the outer guide tube. the guide tubes are intended to be used for guiding electrodes in combination with the elekta/ inomed microdrive during surgical interventions on the brain. the guide tubes are designed to stop in the specific distance to the target, to guide electrodes used for micro electrode recording (mer) and deep brain stimulation (dbs).

Australia - English - Department of Health (Therapeutic Goods Administration)

boston scientific pty ltd - 37307 - brain electrical stimulation system, antitremor - the external trial stimulator is connected from implanted dbs leads to the clinician programmer using an or cable and or cable extension. it allows testing of the stimulation prior to connection and implantation of the vercise ipg the external trial stimulator is used to conduct intraoperative stimulation testing during the implantation procedure for the vercise deep brain stimulation system.

Australia - English - Department of Health (Therapeutic Goods Administration)

boston scientific pty ltd - 37307 - brain electrical stimulation system, antitremor - the vercise ipg is implanted under the clavicle and transmits current via leads implanted in the skull to stimulate specific areas of the brain. the stimulator is controlled by a handheld remote control, and can be interfaced with a clinician?s programmer using the bionic navigator? software. periodically, the stimulator battery must be replenished with an rf charging device provided in the patient dbs charging kit. 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 vercise ipg kit contains the ipg

Australia - English - Department of Health (Therapeutic Goods Administration)

pm separations pty ltd - ct974 - clinical chemistry-specific protein ivds - the clinmass? complete kit with order no. ms2000 is intended for the determination of homocysteine (total homocysteine) from human plasma or serum by lc-ms/ms. the clinspot? complete kit with order no. ms2100 is intended for the determination of homocysteine (total homocysteine) from dried blood spots (dbs) of human origin by lc-ms/ms.