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

biotronik australia pty ltd - 47263 - biventricular pacemaker - enitra 8 hf-t housing is made of biocompatible titanium, welded from the outside and hermetically sealed. the ellipsoid shape facilitates ingrowth into the pectoral muscle area. the housing serves as an antipole in the case of unipolar lead configuration. implantable cardiac resynchronization therapy (crt) pace generator; triple chamber; rate adaptive; unipolar/bipolar; is-1 compatible; home monitoring. mr conditional. enitra is a family of implantable pacemakers that can be implanted for all bradycardia arrhythmia indications. the primary objective of the therapy consists of improving patients' symptoms that can be clinically manifested. the implantation of the pacemaker is a symptomatic therapy with the following objective: ?compensation of bradycardia by atrial, ventricular, or av sequential pacing ?resynchronization of ventricular chamber contraction via biventricular pacing

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

boc ophthalmic instruments pty ltd - 63587 - ophthalmic binocular gauge - the raf binocular gauge is a device for determining the objective and subjective convergence points, measuring accommodation and determining the master eye.

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

microport crm pty ltd - 47270 - biventricular pacemaker/defibrillator - platinium sonr crt-d 1844 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 an 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 platinium 4lv sonr crt-d 1844 is an implantable crt-d indicated in: - 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 ventricular fibrillation induced at electrop

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

microport crm pty ltd - 47270 - biventricular pacemaker/defibrillator - platinium 4lv crt-d 1744 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 an 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. platinium 4lv crt-d 1744 is an implantable crt-d indicated in: - 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 ventricular fibrillation induced at electrophysio

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

abbott medical australia pty ltd - 47533 - implantable ventricular circulatory assist system - hm3 outflow graft clip (clip) is a standalone, implantable component of the hm3 lvas. the clip, has been created to attach to the outflow graft either during initial implantation or as a corrective measure during surgical intervention to mitigate post-operative outflow graft rotation. the clip is a single piece of titanium that mates with the existing features on both the outflow graft assembly and the pump housing, preventing rotation of the outflow graft assembly with respect to the pump. heartmate 3 outflow graft clip is an implantable component of the heartmate 3 left ventricular assist system (hm3 lvas). the hm3 lvas is intended to provide haemodynamic support in patients with advanced, refractory left ventricular heart failure. the clip is for attaching to hm3 sealed outflow graft with bend relief (also an implantable component of the hm3 lvas).

Singapore - English - HSA (Health Sciences Authority)

novem healthcare pte ltd - orthopaedics - pain and decreased articular mobility associated with degenerative lesions of the knee and other synovial joints, including osteoarthritis.

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

medtronic australasia pty ltd - 47270 - biventricular pacemaker/defibrillator - the model dtpc2d4 dual chamber, implantable cardioverter defibrillator with cardiac resynchronization therapy (crt-d) is a multiprogrammable cardiac device that monitors and regulates the patient?s heart rate by providing single or dual chamber, rate-responsive bradycardia pacing; sequential biventricular pacing; ventricular tachyarrhythmia therapies; and atrial tachyarrhythmia therapies. this device features bluetooth wireless technology. lead connector: is-1/df-4. the model dtpc2d4 device is indicated for use in patients who are at significant risk of developing atrial and/or life-threatening ventricular arrhythmias and who have heart failure with ventricular arrhythmias. heart failure patients must have experienced one or more of the following conditions: ? ventricular dyssynchrony ? reduced ejection fraction, regardless of new york heart association (nyha) class, who are indicated for ventricular pacing and have high degree av block ? reduced ejection fraction and all the following characteristics: ? have received a conventional pacemaker or an icd ? have subsequently developed worsening heart failure despite optimal medical therapy ? have a high proportion of rv pacing

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

medtronic australasia pty ltd - 47270 - biventricular pacemaker/defibrillator - the model dtpb2d4 dual chamber, implantable cardioverter defibrillator with cardiac resynchronization therapy (crt-d) is a multiprogrammable cardiac device that monitors and regulates the patient?s heart rate by providing single or dual chamber, rate-responsive bradycardia pacing; sequential biventricular pacing; ventricular tachyarrhythmia therapies; and atrial tachyarrhythmia therapies. this device features bluetooth wireless technology. lead connector type: is-1/df-4 the model dtpb2d4 device is indicated for use in patients who are at significant risk of developing atrial and/or life-threatening ventricular arrhythmias and who have heart failure with ventricular arrhythmias. heart failure patients must have experienced one or more of the following conditions: ? ventricular dyssynchrony ? reduced ejection fraction, regardless of new york heart association (nyha) class, who are indicated for ventricular pacing and have high degree av block ? reduced ejection fraction and all the following characteristics: ? have received a conventional pacemaker or an icd ? have subsequently developed worsening heart failure despite optimal medical therapy ? have a high proportion of rv pacing

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

medtronic australasia pty ltd - 47270 - biventricular pacemaker/defibrillator - the model dtpa2d4 dual chamber, implantable cardioverter defibrillator with cardiac resynchronization therapy (crt-d) is a multiprogrammable cardiac device that monitors and regulates the patient?s heart rate by providing single or dual chamber, rate-responsive bradycardia pacing; sequential biventricular pacing; ventricular tachyarrhythmia therapies; and atrial tachyarrhythmia therapies. this device features bluetooth wireless technology. lead connector type: is-1/df-4 the model dtpa2d4 device is indicated for use in patients who are at significant risk of developing atrial and/or life-threatening ventricular arrhythmias and who have heart failure with ventricular arrhythmias. heart failure patients must have experienced one or more of the following conditions: ? ventricular dyssynchrony ? reduced ejection fraction, regardless of new york heart association (nyha) class, who are indicated for ventricular pacing and have high degree av block ? reduced ejection fraction and all the following characteristics: ? have received a conventional pacemaker or an icd ? have subsequently developed worsening heart failure despite optimal medical therapy ? have a high proportion of rv pacing

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

medtronic australasia pty ltd - 47270 - biventricular pacemaker/defibrillator - the model dtpc2q1 dual chamber, implantable cardioverter defibrillator with cardiac resynchronization therapy (crt-d) is a multiprogrammable cardiac device that monitors and regulates the patient?s heart rate by providing single or dual chamber, rate-responsive bradycardia pacing; sequential biventricular pacing; ventricular tachyarrhythmia therapies; and atrial tachyarrhythmia therapies. this device features bluetooth wireless technology. is4/df-1 the model dtpc2q1 device is indicated for use in patients who are at significant risk of developing atrial and/or life-threatening ventricular arrhythmias and who have heart failure with ventricular arrhythmias. heart failure patients must have experienced one or more of the following conditions: ? ventricular dyssynchrony ? reduced ejection fraction, regardless of new york heart association (nyha) class, who are indicated for ventricular pacing and have high degree av block ? reduced ejection fraction and all the following characteristics: ? have received a conventional pacemaker or an icd ? have subsequently developed worsening heart failure despite optimal medical therapy ? have a high proportion of rv pacing