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

microport crm pty ltd - 60784 - cardiac radio-frequency ablation system - the use of the optimablate cardiac rf generator is indicated in combination with compatible therapeutic catheters for use in intracardiac rf ablation procedures.

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

microport crm pty ltd - 35974 - stimulator, electrical, cardiac, diagnostic - columbus cardiac electrophysiology stimulator is used to impose one or several electric pulse stimulus in certain moment of cardiac cycle, observe the cardiac feedback to the stimulus, learn the cardiac electrophysiologic features, clarify the mechanism of arrhythmia so as to guide clinical diagnosis and treatment for the tachyarrhythmia.

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

microport crm pty ltd - 44772 - tubing set, irrigation pump - optimablate tubing set is a sterile and single use device which provides access for the administration of fluids from a container. this tubing set is intended for use with the optimablate irrigation pump only.

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

microport crm pty ltd - 58771 - drug-eluting coronary artery stent, biodegradable-polymer-coated - the product is a balloon expandable stent with grooves on the outer surface of stent struts. the grooves are coated with a biodegradable drug (rapamycin)/polymer(dl-pla) matrix. the delivery system is a rapid exchange (rx) balloon catheter with effective working length of 140 cm. the firehawk rapamycin target eluting coronary stent system is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions length ? 60 mm with reference vessel diameters of ? 2.25 to ? 4.0 mm.

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

microport crm pty ltd - 47248 - transseptal needle - pathbuilder transseptal needle is indicated for atrial septal puncture when accessing from femoral vein and to build a pathway from the right atrium to the left atrium together with the transseptal guiding introducer. it consists of a thin and curved sections, main body, pointer flange, hub and stylet. the pointer flange indicates the curve orientation and the thin section fits well with that of the dilator which fixes the maximum length of the needle into the dilator pathbuilder transseptal needle is indicated for building a pathway from femoral vein into left atrium through atrial septum puncture.

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

microport crm pty ltd - 36079 - catheter introducer, haemostasis valve - pathbuilder transseptal guiding introducer is designed to introduce various cardiovascular catheters into each heart chamber for further electrophysiology operation. it is comprised of a sheath, a dilator and a guidewire. the sheath has a marker band on the tip to observe the position of catheter at any time, valves to provide hemostasis, and a three-way stopcock on its sideport that can be used for aspiration, fluid infusion, blood sampling and pressure monitoring. pathbuilder transseptal guiding introducer is indicated for introducing various cardiovascular catheters into the heart via femoral vein, including the left side of the heart through the interatrial septum, and when used with cardiovascular catheters, for assisting catheters in reaching the target site.

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

microport crm pty ltd - 36079 - catheter introducer, haemostasis valve - pathbuilder steerable introducer is composed of a steerable sheath, a dilator and a guidewire. it can be inserted into various cardiovascular catheters, including guiding cardiovascular catheters into the left side of the heart. the steerable introducer if fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. a sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring. pathbuilder steerable introducer is indicated for introducing various cardiovascular catheters from femoral vein into left atrium through the interatrial septum, and when used with cardiovascular catheters, for assisting catheters in reaching the target site.

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

microport crm pty ltd - 58771 - drug-eluting coronary artery stent, biodegradable-polymer-coated - the product is a device/drug combination product consisting of a) a stent coated with rapamycin in a biodegradable polymer which filled in grooves on the outer surface of stent struts; and b)a rapid exchange (rx) delivery catheter. the stent is left in the vessel to permanently support the vessel. rapamycin is abluminal on stent struts and is slowly eluted to inhibit proliferation of smooth muscle cells. the coating will degrade and eventually the stent becomes a metal stent. the firehawk liberty? rapamycin target eluting coronary stent system is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (length ? 60 mm) with reference vessel diameters of ? 2.25 to ? 4.0 mm.

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

microport crm pty ltd - 47205 - cardiac pulse generator programmer - cpr4 provides communication with microport implantable pacemakers and defibrillators. by using cpr4, clinicians can improve the patient?s treatment in several ways, including changing the implanted device?s settings, fine-tuning or adapting the therapy to suit patients? needs, and detecting issues with the implanted device or the lead(s) that may result in a required re-intervention (e.g. repositioning, replacement). cpr4 is an inductive programming head intended to be used with compatible microport crm programmers to communicate with microport crm implanted medical devices (imds). cpr4 enables the programmer software modules to be used according to their intended purpose. as an accessory to the programmer software modules, cpr4 is intended to: activate the telemetry, identify the implanted device model, conduct inductive telemetry in order to communicate with the imd.

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

microport crm pty ltd - 31670 - stylet, catheter - stylets are intended for use with implantable pacing and defibrillator leads from sorin group, and are appliced during the implantation procedure. stylets predominantly serve to stiffen the flexible lead during implantation in order to facilitate its positioning.