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

microport crm pty ltd - 47205 - cardiac pulse generator programmer - the orchestra plus link is part of the rf programmer system utilising the orchestra plus programmer. this system has been specially designed to program and interrogate sorin radio frequency implantable medical devices. sorin cardiac devices are equipped with a transceiver which receives clinical commands and sends clinical information and device parameters through the orchestra plus link radio frequency wireless technology. the orchestra plus link is an external device intended to enable a healthcare professional in a clinical setting to noninvasively change the settings of, and extract data from, a sorin group rf enabled implanted cardiac pulse generator (e.g., pacemaker, pacemaker/defibrillator). it is a radio-frequency transmitter/receiver that operates in conjunction the orchestra plus programmer

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

microport crm pty ltd - 35162 - patient data recorder, long-term, electrocardiograph - digital ecg holter recorders intended for multi day ambulatory ecg recording (at 200hz sampling rate). the devices are used to monitor and diagnose cardiac rhythm disorders through analysis of ecg recordings. devices may record relevant physiologic signals for evaluating sleep apnoea syndrome. data is recorded on a removable sd card which is used for clinical analysis.

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

microport crm pty ltd - 47270 - biventricular pacemaker/defibrillator - platinium sonr crt-d 1841 implantable crt-d for the recognition and treatment of ventricular tachycardia and fibrillation with ventricular resynchronisation in patients with spontaneous or inducible tachyarrhythmias.it has accelerometer for adaption of pacing to suit patients activity and rf wireless technology which enables remote monitoring of patients who have the smartview monitor & wireless interrogation & device programming by orchestra plus link the platinium sonr crt-d 1841 is a df4 configured implantable cardioverter defibrillator (crt-d) with ventricular resynchronisation and rate response, with the following indications - patients who are survivors of cardiac arrest due to ventricular fibrillation or hemodynamically unstable sustained vt after evaluation to define the cause of the event and to exclude any completely reversible causes;patients with structural heart disease and spontaneous sustained vt, whether hemodynamically stable or unstable; patients with syncope of undetermined origin with clin

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

microport crm pty ltd - 47270 - biventricular pacemaker/defibrillator - platinium crt-d 1811 implantable crt-d for the recognition and treatment of ventricular tachycardia and fibrillation with ventricular resynchronisation in patients with spontaneous or inducible tachyarrhythmias.it has accelerometer for adaption of pacing to suit patients activity and rf wireless technology which enables remote monitoring of patients who have the smartview monitor & wireless interrogation & device programming by orchestra plus link. the platinium crt-d 1811 is a df1 configured implantable cardioverter defibrillator (crt-d) with ventricular resynchronisation and rate response, with the following indications - patients who are survivors of cardiac arrest due to ventricular fibrillation or hemodynamically unstable sustained vt after evaluation to define the cause of the event and to exclude any completely reversible causes;patients with structural heart disease and spontaneous sustained vt, whether hemodynamically stable or unstable; patients with syncope of undetermined origin with clinically re

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

microport crm pty ltd - 47270 - biventricular pacemaker/defibrillator - platinium crt-d 1711 implantable crt-d for the recognition and treatment of ventricular tachycardia and fibrillation with ventricular resynchronisation in patients with spontaneous or inducible tachyarrhythmias.it has accelerometer for adaption of pacing to suit patients activity and rf wireless technology which enables remote monitoring of patients who have the smartview monitor & wireless interrogation & device programming by orchestra plus link the platinium crt-d 1741 is a df4 configured implantable cardioverter defibrillator (crt-d) with ventricular resynchronisation and rate response, with the following indications - patients who are survivors of cardiac arrest due to ventricular fibrillation or hemodynamically unstable sustained vt after evaluation to define the cause of the event and to exclude any completely reversible causes;patients with structural heart disease and spontaneous sustained vt, whether hemodynamically stable or unstable; patients with syncope of undetermined origin with clinically rel

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

microport crm pty ltd - 47270 - biventricular pacemaker/defibrillator - platinium crt-d 1711 implantable crt-d for the recognition and treatment of ventricular tachycardia and fibrillation with ventricular resynchronisation in patients with spontaneous or inducible tachyarrhythmias.it has accelerometer for adaption of pacing to suit patients activity and rf wireless technology which enables remote monitoring of patients who have the smartview monitor & wireless interrogation & device programming by orchestra plus link the platinium crt-d 1711 is a df1 configured implantable cardioverter defibrillator (crt-d) with ventricular resynchronisation and rate response, with the following indications - patients who are survivors of cardiac arrest due to ventricular fibrillation or hemodynamically unstable sustained vt after evaluation to define the cause of the event and to exclude any completely reversible causes;patients with structural heart disease and spontaneous sustained vt, whether hemodynamically stable or unstable; patients with syncope of undetermined origin with clinically rel

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

microport crm pty ltd - 37265 - defibrillator, implantable, automatic, dual-chamber - the platinium dr 1540 is a df-4 configured dual chamber implantable defibrillator, and is to be implanted in the patient for monitoring the patient's electrocardiogram (ecg). it is equipped with the rf wireless technology which enables remote monitoring of patients who have the sorin smartview monitor installed at home or wireless interrogation and device programming with the orchestra plus programmer equipped with orchestra plus link accessory. platinium dr 1540 is an implantable dual chamber cardioverter defibrillator with rate response, with the following indications - patients who are survivors of cardiac arrest due to ventricular fibrillation or hemodynamically unstable sustained vt after evaluation to define the cause of the event and to exclude any completely reversible causes;patients with structural heart disease and spontaneous sustained vt, whether hemodynamically stable or unstable; patients with syncope of undetermined origin with clinically relevant hemodynamically significant sustained vt or v

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

microport crm pty ltd - 37265 - defibrillator, implantable, automatic, dual-chamber - the platinium dr 1510 is a df-1 configured dual chamber implantable defibrillator, and is to be implanted in the patient for monitoring the patient's electrocardiogram (ecg). it is equipped with the rf wireless technology which enables remote monitoring of patients who have the sorin smartview monitor installed at home or wireless interrogation and device programming with the orchestra plus programmer equipped with orchestra plus link accessory. platinium dr 1510 is an implantable dual chamber cardioverter defibrillator with rate response, with the following indications - patients who are survivors of cardiac arrest due to ventricular fibrillation or hemodynamically unstable sustained vt after evaluation to define the cause of the event and to exclude any completely reversible causes;patients with structural heart disease and spontaneous sustained vt, whether hemodynamically stable or unstable; patients with syncope of undetermined origin with clinically relevant hemodynamically significant sustained vt or v

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

microport crm pty ltd - 35852 - defibrillator, implantable, automatic - the platinium vr 1210 is a df-1 configured single chamber implantable defibrillator, and is to be implanted in the patient for monitoring the patient's electrocardiogram (ecg). it is equipped with the rf wireless technology which enables remote monitoring of patients who have the sorin smartview monitor installed at home or wireless interrogation and device programming with the orchestra plus programmer equipped with orchestra plus link accessory. platinium vr 1210 is an implantable single chamber cardioverter defibrillator with rate response, with the following indications - patients who are survivors of cardiac arrest due to ventricular fibrillation or hemodynamically unstable sustained vt after evaluation to define the cause of the event and to exclude any completely reversible causes;patients with structural heart disease and spontaneous sustained vt, whether hemodynamically stable or unstable; patients with syncope of undetermined origin with clinically relevant hemodynamically significant sustained vt

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

microport crm pty ltd - 35852 - defibrillator, implantable, automatic - the platinium vr 1240 is a df-4 configured single chamber implantable defibrillator, and is to be implanted in the patient for monitoring the patient's electrocardiogram (ecg). it is equipped with the rf wireless technology which enables remote monitoring of patients who have the sorin smartview monitor installed at home or wireless interrogation and device programming with the orchestra plus programmer equipped with orchestra plus link accessory. platinium vr 1240 is an implantable single chamber cardioverter defibrillator with rate response, with the following indications - patients who are survivors of cardiac arrest due to ventricular fibrillation or hemodynamically unstable sustained vt after evaluation to define the cause of the event and to exclude any completely reversible causes;patients with structural heart disease and spontaneous sustained vt, whether hemodynamically stable or unstable; patients with syncope of undetermined origin with clinically relevant hemodynamically significant sustained vt