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

medtronic australasia pty ltd - 44085 - information system software, application program, - medtronic deep brain stimulation (dbs) care management computer system provide neuroogists, neurological support staff and neurosurgeons with information pertaining to dbs programming tasks and the management of patient programming records. it does not directly interact with dbs system itself.

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

boston scientific pty ltd - 37307 - brain electrical stimulation system, antitremor - the vercise pc system includes a 16-contact, multi-channel implantable pulse generator (ipg) with a non-rechargeable battery as the power source. the vercise pc system includes a 16-contact, multi-channel implantable pulse generator (ipg) with a non-rechargeable battery as the power source. the primary cell ipg kit consisting of ipg, ipg port plugs and surgical accessories. 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 p

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

roche diagnostics australia pty limited - 48441 - hiv1/hiv2 nucleic acid ivd, kit, nucleic acid technique (nat) - cobas hiv-1/hiv-2 qualitative is a qualitative test performed on the cobas 6800 system and cobas 8800 system. it enables the simultaneous detection and discrimination of hiv-1 and hiv-2 nucleic acid in edta plasma, serum and dbs of infected patients. two probes are used to detect hiv-1, but not to discriminate group m subtypes of hiv-1 and of hiv-1 group o and group n. a third probe is used to detect hiv-2, but not to discriminate hiv-2 group a and group b. nucleic acid amplification test for the qualitative detection and differentiation of human immunodeficiency virus (hiv) type 1 (hiv-1) and type 2 (hiv-2) in human serum, plasma, and dried blood spots (dbs)

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

boston scientific pty ltd - 33658 - implant battery charger - the charging system for the stimulator consists of the charger, a base station, and a power supply. the boston scientific dbs system includes a rechargeable stimulator that will require periodic recharging. the charging system allows patients to recharge the stimulator battery as needed.

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

boston scientific pty ltd - 37307 - brain electrical stimulation system, antitremor - the vercise gevia system includes the rechargeable vercise gevia implantable pulse generator (ipg, also known as the vercise gevia stimulator). the contents of the vercise gevia implantable pulse generator kit are: ? stimulator ? stimulator template ? stimulator header plugs ? torque wrench the vercise gevia 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.

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

medtronic australasia pty ltd - 61393 - multi-purpose electrical stimulation system programmer - the model a610 clinician programmer application (cpa) for deep brain stimulation is a stand-alone software application installed on a tablet, an off-the-shelf mobile platform that is a non-medical device the medtronic clinician programmer software a610 is intended for use by clinicians in the programming of neurostimulators (external and implantable) for deep brain stimulation (dbs).

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

medtronic australasia pty ltd - 61393 - multi-purpose electrical stimulation system programmer - the medtronic clinician programmer software a610 is intended for use by clinicians in the programming of neurostimulators (external and implantable) for deep brain stimulation (dbs)

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

medtronic australasia pty ltd - 61393 - multi-purpose electrical stimulation system programmer - the model a620 activa patient programmer application software loaded on the cots handset is utilized by the patient to view therapy settings and battery status, as well to adjust dbs therapy within clinician-defined parameters. the medtronic model a620 activa patient programmer application is intended for use by patients in viewing and adjusting dbs therapy, within clinician-defined limits, with the activa family of implantable neurostimulators.

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

medtronic australasia pty ltd - 61393 - multi-purpose electrical stimulation system programmer - the medtronic th91d kit contains the tm91 communicator and the hh90 handset. the dbs patient programmer application a620 is intended to be used for controlling dbs therapy. the app is installed on and used with the handset to adjust therapy using the tm91 communicator to connect with the implanted neurostimulator

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

medtronic australasia pty ltd - 37307 - brain electrical stimulation system, antitremor - the percept pc system is an active implantable device system for deep brain stimulation (dbs) and sensing of bioelectric signals in the brain. therapy for movement disorders is indicated for stimulation of the ventral intermediate nucleus (vim) for patients with disabling essential tremor (et) or parkinsonian tremor, or stimulation of the internal globus pallidus (gpi) or the subthalamic nucleus (stn) for patients with symptoms of parkinson's disease (pd). dbs therapy for movement disorders is also indicated for the stimulation of the internal globus pallidus (gpi) or the subthalamic nucleus (stn) as an aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and segmental dystonia, hemidystonia and cervical dystonia (torticollis) for individuals 7 years and older. bilateral anterior thalamic nucleus (ant) stimulation using the medtronic dbs system for epilepsy is indicated as adjunctive therapy for reducing the frequency of seizures in adults diagnosed with epilepsy characterized by partial-onset seizures, with or without secondary generalization, that are refractory to antiepileptic medications. medtronic dbs therapy is indicated for bilateral stimulation of the anterior limb of the internal capsule, aic, as an adjunct to medications and as an alternative to anterior capsulotomy for the treatment of chronic, severe, treatment-resistant ocd in adult patients who have failed at least three selective serotonin reuptake inhibitors (ssris)