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

abbott medical australia pty ltd - 37307 - brain electrical stimulation system, antitremor - the extensions are designed to connect the lead to the ipg. one end is designed to receive the proximal end of the lead, and the opposite end is designed for insertion and connection with the ipg. the 8-channel infinity extensions connect to 8-channel infinity leads. infinity extensions have coloured bands that can help during implantation to differentiate between the right and left sides of the body. the devices (except model 6373) are mr conditional. deep brain stimulation extensions are intended to connect the leads to implantable pulse generators.

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

abbott medical australia pty ltd - 37307 - brain electrical stimulation system, antitremor - the dbs coiled extension is fabricated from materials that allow it to stretch inside the patient?s body and the kit is used within a compatible deep brain stimulation system. the extension kit also includes a torque wrench and a tunnelling tool. the deep brain stimulation lead extensions are intended to connect the lead to the implantable pulse generators (ipgs).

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

boston scientific pty ltd - 61552 - deep brain electrical stimulation system lead - one end of the dbs lead is implanted in the skull and the other end is attached to the vercise ipg. a current is passed from the ipg, down the lead to stimulate a specific area of the brain. 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 dbs lead kit contains a dbs lead with pre-loaded stylet, torque wrench, lead boot, lead stop and four suture sleeves.

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

medtronic australasia pty ltd - 44040 - neural-tissue electrical stimulation lead - the model 3391 dbs lead is an implantable component of the multiprogrammable system-reclaim dbs therapy for ocd and is designed to electrically stimulate specific areas of the brain. the lead features 4.0mm spacing between each of the four 3.0mm electrodes at the distal end. the electrode spread is 24.0mm. accessories with the lead include straight & short stylet, torque wrench, screening cables, depth stop gauge, burr hole ring & cap, connector boot, tunnelling tool & tips, tubes and lead cap. the medtronic reclaim 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 treatment of chronic, severe, treatment resistant obsessive-compulsive disorder (ocd)in adult patients who have failed at least three selective serotonin reuptake inhibitors (ssris).

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

abbott medical australia pty ltd - 45252 - active-implantable-device communicator - the libra clinician programmer controls the creation and adjustment of all programming parameters. the programmer uses radio-frequency signals to communicate with the ipg. the clinician programmer is intended to program the stimulation parameters of libra neurostimulators via radio frequency telemetry.

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

abbott medical australia pty ltd - 37307 - brain electrical stimulation system, antitremor - the deep brain stimulation lead is an implantable lead with four electrodes on the distal end. deep brain stimulation leads are intended to deliver electrical stimulation to specific targets in the brain.

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

abbott medical australia pty ltd - 45252 - active-implantable-device communicator - the athena programmer is a computer that interfaces with advanced neuromodulation systems deep brain stimulation (dbs) systems and is intended to be used to noninvasively adjust dbs system parameters. the accessories provided with the athena programmer include communication cable, six-cell battery, ac power adapter, sd card, ir adapter, spare battery charger, wand holder. the athena programmer is intended for post-operative programming of stimulation parameters for advanced neuromodulation systems deep brain stimulation (dbs) systems.

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

medtronic australasia pty ltd - 45252 - active-implantable-device communicator - the patient programmer communicates with the neurostimulator by sending signals to and receiving signals from the neurostimulator. it's used to control and monitor the implanted neurostimulator. for example to turn on/off therapy; change therapy settings; record seizure or aura; reset stimulation cycle; check neurostimulator and patient programmer batteries; alert patient when they need to check the neurostimulator battery. the programmer is held directly over the implanted neurostimulator. the medtronic patient programmer, model 37441 is designed to program the medtronic activa pc model 37601 neurostimulator

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

abbott medical australia pty ltd - 37307 - brain electrical stimulation system, antitremor - the libra model 6608 is an 8-channel ipg designed to be connected to one dbs lead extension. the libra ipg is designed to deliver electrical stimulation to specific targets in the brain via leads and associated extensions that are compatible with the libra dbs system.

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

abbott medical australia pty ltd - 37307 - brain electrical stimulation system, antitremor - the libra xp model 6644 is a dual 4-channel ipg designed to be connected to two dbs lead extensions. the libra ipg is designed to deliver electrical stimulation to specific targets in the brain via leads and associated extensions that are compatible with the libra dbs system.