オーストラリア - 英語 - 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.

オーストラリア - 英語 - 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.

オーストラリア - 英語 - 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.

オーストラリア - 英語 - 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.

オーストラリア - 英語 - 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.

オーストラリア - 英語 - 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.

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

livanova australia pty ltd - 46242 - surgical support tape, non-absorbable - vasco loops are indicated for use in occluding vessels to stop the flow of blood to the surgical site or positioning an organ in order to provide improved view of the surgical field.

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

livanova australia pty ltd - 46115 - catheter adaptor, general purpose - the straight adapter is indicated for use during cardiopulmonary bypass surgery for connecting a cannula or catheter to an administration and/or a vent line. the venting ?y? adapter is designed to be used in conjunction with cardiopulmonary bypass surgery to deliver cardioplegia solution, and venting the left atrium of the heart. it may also be used as an extension line by itself. the recirculation ?y? adapter is indicated for use for recirculating of cardioplegia solution during cardiopulmonary bypass surgery, to keep the cardioplegia solution at a constant temperature. the perfusion ?y? adapter is indicated for use in delivery of cardioplegia solution during cardiopulmonary bypass surgery. the multiple perfusion adapter is designed to deliver cardioplegia solution through an aortic root cannula while also perfusing up to three vein grafts with appropriate cannula. the multiple perfusion adapter with vent line models of the cardioplegia delivery sets are designed to deliver cardioplegia solution through an aortic root cannula while also perfusing up to three vein grafts. the multiple perfusion adapter with vent line with vessel cannula is designed to deliver cardioplegia solution through an aortic root cannula while also perfusing up to three vein grafts. the multiple perfusion adapter with vessel cannula is designed to deliver cardioplegia solution through an aortic root cannula while also perfusing up to three vein grafts. the multiple perfusion adapter with vessel cannula with valve is designed to deliver cardioplegia solution through an aortic root cannula while also perfusing up to three vein grafts.

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

livanova australia pty ltd - 34923 - catheter, suction, general-purpose - suction wands and sumps are indicated for use in removing excess fluid from the surgical field.

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

livanova australia pty ltd - 11268 - dilator, vascular - the sorin vascular dilator kit consists of a scalpel, insertion needle, guidewire, and a set of 5 dilators (8, 12, 16, 20, and 24 french). the kit is intended for use in dilating a vessel to aid in introduction of a catheter or cannula. the kit is packaged sterile and intended for single use.