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

abbott medical australia pty ltd - 61785 - cardiac radio-frequency ablation system catheter - the catheter is constructed of thermoplastic elastomer material and noble metal electrodes with a tri-axial optical force sensor to measure contact force at the tip. it facilitates electrophysiological mapping of the heart and transmits radiofrequency current to the tip electrode for intracardiac ablation. it has fluid lumen for saline irrigation during the ablation procedure. the tip curvature of the bi-directional catheter is manipulated by the control mechanism located on the handle. the tacticath contact force ablation catheter, sensor enabled is indicated for use in cardiac electrophysiological mapping (stimulation and recording), and, when used in conjunction with a radiofrequency generator, for cardiac ablation of supraventricular arrhythmias in right and left atrium, including atrial fibrillation.

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

abbott medical australia pty ltd - 61785 - cardiac radio-frequency ablation system catheter - the catheter is constructed of thermoplastic elastomer material and noble metal electrodes with a tri-axial optical force sensor to measure contact force at the tip. it facilitates electrophysiological mapping of the heart and transmits radiofrequency current to the tip electrode for intracardiac ablation. it has fluid lumen for saline irrigation during the ablation procedure. the tip curvature of the uni-directional catheter is manipulated by the control mechanism located on the handle. the tacticath contact force ablation catheter, sensor enabled is indicated for use in cardiac electrophysiological mapping (stimulation and recording), and, when used in conjunction with a radiofrequency generator, for cardiac ablation of supraventricular arrhythmias in right and left atrium, including atrial fibrillation.

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

abbott medical australia pty ltd - 46355 - electrophysiology cardiac catheter, single-use - the catheters are steerable, flexible, insulated electrophysiology catheters constructed of thermoplastic elastomer material and noble metal electrodes. the shaft curvature is manipulated by the shaft deflection mechanism located on the handle at the catheter?s proximal end. to adjust the curve on the bi-directional catheter, use the actuator on the handle to deflect the catheter in either direction. to adjust the loop diameter, rotate the loop actuator in either direction. advisor vl circular mapping catheter, sensor enabled is a steerable electrophysiology catheter with integrated sensors. the catheter is used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies. the catheter can be used to map the atrial regions of the heart.

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

abbott medical australia pty ltd - 46355 - electrophysiology cardiac catheter, single-use - advisor vl circular mapping catheters, sensor enabled are steerable, flexible, insulated electrophysiology catheters constructed of thermoplastic elastomer material and noble metal electrodes. to adjust the curve on the uni-directional catheter, push or pull the thumb control located on the handle. to adjust the loop diameter, rotate the loop actuator in either direction. advisor vl circular mapping catheter, sensor enabled is a steerable electrophysiology catheter with integrated sensors. the catheter is used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies. the catheter can be used to map the atrial regions of the heart.

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

abbott medical australia pty ltd - 36007 - stimulator, electrical, analgesic, spinal cord - dorsal root ganglion implant leads are designed for percutaneous introduction into the body using a special needle and a set of custom delivery tools provided in the lead kit. the lead is fitted with four cylindrical electrodes spaced at equal intervals, which are intended to provide stimulation at the target dorsal root ganglion. a lead extension can be used to add length to the lead and tunneling tool can assist in providing a pathway for the lead to the pulse generator. the lead is intended to be used with a compatible neurostimulation system for dorsal root ganglion (drg) stimulation by connecting to the pulse generator, either directly or with a compatible lead extension.

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

abbott medical australia pty ltd - 36007 - stimulator, electrical, analgesic, spinal cord - dorsal root ganglion implant leads are designed for percutaneous introduction into the body using a special needle and a set of custom delivery tools provided in the lead kit. the lead is fitted with four cylindrical electrodes spaced at equal intervals, which are intended to provide stimulation at the target dorsal root ganglion. a lead extension can be used to add length to the lead and tunneling tool can assist in providing a pathway for the lead to the pulse generator. the lead is intended to be used with a compatible neurostimulation system for dorsal root ganglion (drg) stimulation by connecting to the pulse generator, either directly or with a compatible lead extension. model number mn20450-50a is mr conditional.

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

abbott medical australia pty ltd - 36007 - stimulator, electrical, analgesic, spinal cord - the ipg is designed to be connected to one or more leads or extensions with up to 16 electrodes total, is powered by a hermetically sealed battery within a titanium case, uses microelectronic circuitry to generate constant-current electrical stimulation & can deliver stimulation with a single program or with multiple programs. each programme can provide stimulation to a single anatomical area or to multiple areas. the ipg communicates wirelessly with system programmers & controllers. the neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. the system is intended to be used with leads and associated extensions that are compatible with the system.

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

abbott medical australia pty ltd - 36007 - stimulator, electrical, analgesic, spinal cord - the proximal terminal end of the lead extension is inserted into the implantable pulse generator (ipg) header to transmit the electrical stimulation generated by the ipg. it consists of four electrodes and an end cap. the silicone port header on the distal end contains four electrical contacts designed to contact the electrodes on the proximal terminal end of a drg lead when it is inserted into the header. lead extension is intended to add length to a lead used with neurostimulators for dorsal root ganglion (drg) stimulation. lead extension can be temporarily externalised to join a lead to a trial stimulator or permanently implanted to join a lead to a compatible neurostimulator.

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

abbott medical australia pty ltd - 45418 - cardiac occluder - the amplatzer piccolo occluder is a self-expanding nitinol mesh device for the occlusion of a patent ductus arteriosus. the device has two end retention discs and a central waist, providing several degrees of freedom of motion to conform to the physiology of the ductus to allow for better occlusion. the device has a symmetrical design allowing for venous or arterial approach during implantation. the amplatzer piccolo occluder is a percutaneous, transcatheter occlusion device intended for the nonsurgical closure of a patent ductus arteriosus (pda).

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

abbott medical australia pty ltd - 42410 - holder, cable/lead - the lead and extension insertion tool is a hand-manipulated device that is intended to help insert the terminal end of a neurostimulation lead, extension, or adapter into the header of an implantable pulse generator during implantation of a neurostimulation system.