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

medtronic australasia pty ltd - 61393 - multi-purpose electrical stimulation system programmer - the th90dxx kit contains the tm90 communicator that is intended for use with the non-medical cots handset (hh90 samsung smart phone). the activa patient programmer app a620 is used to view and adjust dbs therapy within clinician-defined limits for the medtronic activa neurostimulator for dbs therapy connecting to the implanted device through the tm90 communicator. the xx indicates the intended country to meet electrical safety standards. the medtronic th90d kit contains the tm90 communicator and the hh90 handset. the activa patient programmer app a620 is intended to be used for viewing and adjusting dbs therapy within clinician-defined limits. the app is installed on and used with the handset using the tm90 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 medtronic model b35200 percept? pc neurostimulator with brainsense? is part of an active implantable device system for deep brain stimulation and sensing. the dbs system delivers electrical stimulation to targeted regions of the brain to suppress the symptoms associated with a neurologic disorder treatable by brain stimulation. 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)

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

medtronic australasia pty ltd - 61393 - multi-purpose electrical stimulation system programmer - the th91d kit contains the tm91 communicator that is intended for use with the non-medical cots handset. the dbs patient programmer application a620 is used to view or adjust dbs therapy connecting to the implanted device through the tm91 communicator. the model a620 dbs patient programming application, along with the th91d handset and communicator kit, is intended to be used to view or adjust dbs therapy, as prescribed by your dbs clinician.

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

medtronic australasia pty ltd - 44063 - surgical procedure kit, neurosurgical, single-use, non-medicated - the extension test cable is an external device intended to conduct electrical stimulation from the external neurostimulator to the extension dbs lead.

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

medtronic australasia pty ltd - 44063 - surgical procedure kit, neurosurgical, single-use, non-medicated - the lead test cable is an external device intended to conduct electrical stimulation from the external neurostimulator to the implanted dbs lead.

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

medtronic australasia pty ltd - 37307 - brain electrical stimulation system, antitremor - the sensight lead system are implanted devices intended to conduct electrical stimulation to the intended target as part of a dbs system.

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

boston scientific pty ltd - 33658 - implant battery charger - the charging system is a non-implantable component of the dbs system and is intended to recharge the battery of rechargeable ipgs. the system consists of a charger, base station, power supply and charging belt that holds the charger over the stimulator. the vercise charging system with belt is a component of the vercise dbs system which 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 that is not adequately controlled with medication. ? unilateral or bilateral stimulation of the subthalamic nucleus (stn) or internal globus pallidus (gpi) for treatment of intractable primary and secondary dystonia, for persons 7 years of age and older. ? thalamic stimulation for the suppression of tremor that is not adequately controlled by medications in patients diagnosed with essential tremor or parkinson?s disease.

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

boston scientific pty ltd - 37307 - brain electrical stimulation system, antitremor - 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

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

boston scientific pty ltd - 37307 - brain electrical stimulation system, antitremor - 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.

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

boston scientific pty ltd - 37307 - brain electrical stimulation system, antitremor - the vercise genus system includes the primary cell 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.