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

livanova australia pty ltd - 34210 - antiseizure/psychiatric-therapy vagus nerve electrical stimulation system - model 502 accessory pack - includes back-up sterile test resistor, lead tie-downs and hex screwdriver.

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

livanova australia pty ltd - 46410 - surgical procedure kit, cardiothoracic, non-medicated, single-use - the custom tubing pack is indicated for use in cardiothoracic surgical procedures requiring extracorporeal support. the custom tubing pack may consist of any or all of these devices such as oxygenators, cardiotomy reservoirs, centrifugal blood pump head, blood filters, and heat exchangers. this device is single use and non-medicated.

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

livanova australia pty ltd - 35950 - vascular graft tunneller - model 402 tunneller - a disposable surgical tool used for subcutaneous tunneling of the lead assembly from the nerve site in the neck to the pulse generator site in the chest.

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

livanova australia pty ltd - 34210 - antiseizure/psychiatric-therapy vagus nerve electrical stimulation system - the pulse generator is an implantable, multiprogrammable pulse generator that delivers electrical signals to the vagus nerve. the pulse generator is housed in a hermetically sealed titanium case and is powered by a single battery. electrical signals are transmitted from the pulse generator to the vagus nerve by the lead. the lead and the pulse generator make up the implantable portion of the vns therapy system. the demipulse duo model 104 generator is compatible with the dual-pin lead. the vagus nerve stimulator therapy system is indicated for the treatment of chronic or recurrent depression in patients that are in a treatment resistant or treatment intolerant major depressive episode and for use as an adjunctive therapy in reducing the frequency of seizures in patients whose epileptic disorder is dominated by partial seizures or generalised seizures that are refractory to antiepileptic medications.

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

livanova australia pty ltd - 44041 - electrode/lead, stimulator, implantable, vagus nerve - the lead is bifurcated at 1 end and has a single connector pin at the other - compatible with single-receptacle generators. the lead insulated with silicone, delivers an electrical signal from the generator to the vagus nerve. available in two sizes (2.0 and 3.0 mm electrode diameter) to ensure optimal electrode fit on the nerve. the lead has 2 helical electrodes and an anchor tether, which coil around the left vagus nerve. the connector end is tunnelled subcutaneously to the generator pocket. model 303 lead - silicone insulated implantable patient lead, delivering the electrical signal from the pulse? (model 102) or demipulse? (model 103) generators to the vagus nerve. the lead has at one end, two helical electrodes and an anchor tether, which are coiled around the vagus nerve. the opposite end of the lead has a single connector, which is tunneled subcutaneously from the vagus nerve and inserted into the generator. the lead is available in multiple sizes to accommodate different nerve sizes.

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

livanova australia pty ltd - 44041 - electrode/lead, stimulator, implantable, vagus nerve - the lead is bifurcated at 1 end and has a single connector pin at the other - compatible with single-receptacle generators. the lead insulated with silicone, delivers an electrical signal from the generator to the vagus nerve. available in two sizes (2.0 and 3.0 mm electrode diameter) to ensure optimal electrode fit on the nerve. the lead has 2 helical electrodes and an anchor tether, which coil around the left vagus nerve. the connector end is tunnelled subcutaneously to the generator pocket. model 304 lead - silicone insulated implantable patient lead, delivering the electrical signal from the pulse? (model 102) or demipulse? (model 103) generators to the vagus nerve. the lead is bifurcated at one end with two helical electrodes and an anchor tether, which are coiled around the vagus nerve. the opposite end of the lead has a single connector, which is tunneled subcutaneously from the vagus nerve and inserted into the generator. the lead is available in multiple sizes to accommodate different nerve sizes.

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

livanova australia pty ltd - 36777 - suction unit, electric powered - a vacuum module that is intended to operate both in a standalone mode and as an accessory to an autologous blood recovery system for intraoperative and postoperative recovery of blood for the evacuation of the surgical field.

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

livanova australia pty ltd - 44077 - programmer, implantable stimulator, vagus nerve - the vns therapy? system programmer a small hand-held tablet computer enabling the interrogation and programming of the cyberonics? vns therapy? implantable pulse generator range using the programming wand. the vns therapy? system model 250 programmer enables the treating physician to program and interrogate the vns therapy? implantable pulse generator (ipg) range.

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

livanova australia pty ltd - 34210 - antiseizure/psychiatric-therapy vagus nerve electrical stimulation system - the vns therapy generator is an implantable, multiprogrammable pulse generator that delivers electrical signals to the vagus nerve. the pulse generator is housed in a hermetically sealed titanium case and is powered by a single battery. electrical signals are transmitted from the pulse generator to the vagus nerve by the lead. the lead and the pulse generator make up the implantable portion of the vns therapy system. the vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients whose epileptic disorder is dominated by partial seizures (with or without secondary generalization) or generalized seizures that are refractory to seizure medications. for the purpose of identifying potential patients who may benefit from using the autostim feature of the model 106 generator, ictal tachycardia shall be defined as an increase in heart rate during a seizure, specifically from a baseline heart rate to a rate that is greater than 100 bpm and is at least a 55% increase or 35 bpm increase from baseline. autostim produces stimulation similar in intent to the on-demand stimulation provided by the magnet mode. if autostim is enabled, stimulation is initiated automatically upon detection of a physiologic signal indicative of the onset of a seizure for some patients. the sensitivity of the detection can be adjusted.

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

livanova australia pty ltd - 47800 - surgical fluid/gas irrigator - the mister is intended for use during procedures when a wound or surgical site must be cleared by non-contact means for improved visibility at the site.