Austrália - inglês - Department of Health (Therapeutic Goods Administration)

microport crm pty ltd - 47267 - single-chamber pacemaker, rate-responsive - alizea sr pacemaker pacemaker is a rate responsive single chamber pacemaker. the devices automatically respond to bradycardia by providing atrial and/or ventricular pacing through the delivery of electrical impulses. the pacemakers are also equipped with physiological sensor(s). alizea sr pacemaker is indicated for symptomatic paroxysmal or permanent second- or third-degree av block; symptomatic bilateral bundle branch block; symptomatic paroxysmal or transient sinus node dysfunctions with or without associated av conduction disorders; bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias; vasovagal syndromes or hypersensitive carotid sinus syndromes. rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in minute ventilation and/or activity. the device(s) are mr conditional in the 1.5t and 3t mr environments only.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

microport crm pty ltd - 47267 - single-chamber pacemaker, rate-responsive - borea sr pacemaker is a rate responsive single chamber pacemaker. the devices automatically respond to bradycardia by providing atrial and/or ventricular pacing through the delivery of electrical impulses. the pacemakers are also equipped with physiological sensor(s). borea sr pacemaker is indicated for symptomatic paroxysmal or permanent second- or third-degree av block; symptomatic bilateral bundle branch block; symptomatic paroxysmal or transient sinus node dysfunctions with or without associated av conduction disorders; bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias; vasovagal syndromes or hypersensitive carotid sinus syndromes. rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in minute ventilation and/or activity. the device(s) are mr conditional in the 1.5t and 3t mr environments only.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

microport crm pty ltd - 47267 - single-chamber pacemaker, rate-responsive - celea sr pacemaker is a rate responsive single chamber pacemaker. the devices automatically respond to bradycardia by providing atrial and/or ventricular pacing through the delivery of electrical impulses. the pacemakers are also equipped with physiological sensor(s). celea sr pacemaker is indicated for symptomatic paroxysmal or permanent second- or third-degree av block; symptomatic bilateral bundle branch block; symptomatic paroxysmal or transient sinus node dysfunctions with or without associated av conduction disorders; bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias; vasovagal syndromes or hypersensitive carotid sinus syndromes. the device(s) are mr conditional in the 1.5t and 3t mr environments only. rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in minute ventilation and/or activity.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

microport crm pty ltd - 60910 - coronary venous pacing lead - navigo 4lv is a quadripolar coronary venous lead, intended to be used with implantable pacemakers or defibrillators with ventricular resynchronization therapy providing chronic left ventricular pacing. the lead can be guided towards the left ventricle through a coronary vein using either the stylet or the ?over-the-wire? technique. the navigo 4lv leads have been tested for use in the magnetic resonance imaging (mri) environment. the leads are full body 1.5t and 3t mr conditional. the navigo 4lv lead is for chronic left-ventricular pacing through a coronary vein. it is intended to be used in conjunction with a pacemaker or defibrillator for permanent pacing of the left ventricle for cardiac resynchronization therapy (crt-p or crt-d) with an is4-llll port.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

microport crm pty ltd - 46717 - pacing/defibrillation lead stylet - the navigo re-intervention kit provides additional accessories for using during implant, or re-intervention, of the navigo 4lv leads family. this includes: - silicone suture sleeve to secure the lead in place - funnel to flush the lead's lumen and facilitate stylet insertion - stylets to provide additional stiffness to the lead body - torquer to facilitate manipulation of the guidewire - clipsa tool, pacing system analyser (psa) adaptor, to facilitate accurate electrical measurements the navigo re-intervention kit is intended to be used with the navigo 4lv leads family only and provides additional accessories at implant or re-intervention.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

microport crm pty ltd - 35223 - lead, pacemaker, implantable, endocardial - the vega lead is a bipolar, endocardial, steroid eluting, silicone-insulated lead with silglide surface treatment to improve the lead's gliding properties. it is an active fixation lead with an extendable/retractable fixation helix for permanent pacing and sensing of either the atrium or ventricle. the lead is designed to be used with implantable cardiac pacemakers and defibrillators. the device is 1.5t and 3t mr conditional. the vega leads are designed to be used with implantable cardiac pacemakers and defibrillators. the leads performances are: - to deliver to the heart cells in the near of the tip electrode the pacing pulses generated by the connected pacemaker/defibrillator (pacing function), - to deliver to the connected pacemaker/defibrillator the electrical signals generated by the heart spontaneous contraction (sensing function)

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

microport crm pty ltd - 46717 - pacing/defibrillation lead stylet - the sonrtip re-intervention kit provides additional accessories at implant or re-intervention: - the vein lifter, to aid venous insertion of the lead. - the funnel, to facilitate stylet insertion into sonr is-1 lead connector. - the stylets, to provide additional stiffness to the lead body and controlled flexibility for maneuvering the lead into position. - the silicone suture sleeve, to secure the lead in place. the sonrtip re-intervention kid is intended to be used with the sonrtip lead only and contains additional accessories required during implantation or re-intervention.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

microport crm pty ltd - 35223 - lead, pacemaker, implantable, endocardial - the sonrtip lead is an atrial endocardial lead equipped with the cardiac contractility sensor designed to be used with all microport icd's equipped with the sonr function. the sensor, inserted in the lead tip, is contained in a hermaetically sealed cylindrical titanium capsule. it has 2 main parts - a microaccelerometer measures heart muscle acceleration, while its electronic circuit transmits the signals to the compatible device, thus able to measure and record cardiac contractility. the sonrtip lead has cardiac pacing and sensing capabilities.the sonrtip lead is indicated for use with all microport cardiac resynchronisation therapy defibrillators equipped with the sonr function.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

microport crm pty ltd - 37096 - cable, - cable intended to provide an electrical connection between compatible electrophysioliogy products

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

microport crm pty ltd - 46007 - cardiac mapping system reference patch - to provide a reference location relative to an ablation catheter when used in conjunction with the a navigation system.