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

biotronik australia pty ltd - 47267 - single-chamber pacemaker, rate-responsive - edora 8 sr-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 pulse generator, single chamber, rate adaptive, unipolar/bipolar, is-1 compatible, with home monitoring. promri? labelled mri conditional pacemakers are conditionally safe for use in the mri environment (mr conditional) edora 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 or ventricular pacing

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

biotronik australia pty ltd - 44900 - pacemaker/defibrillator port safety plug - the bs is4 blind plug securely closes and seals unused is4 connector ports in the header of implantable pacemakers and icds. blind plug parts may have body contact. the devices are mr conditional. the bs is4 blind plug securely closes and seals unused is4 connector ports in the header of implantable pacemakers and icds.

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

biotronik australia pty ltd - 53616 - bare-metal coronary artery stent - it is used for for improving coronary luminal diameter in the following: ? patients with symptomatic ischemic heart disease due to discrete de novo and restenotic native coronary artery lesions or lesions in saphenous vein bypass grafts with a reference diameter ranging between ? 2.0 mm to ? 5.0 mm. ? in the treatment of acute or threatened occlusion associated with a coronary intervention.

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

biotronik australia pty ltd - 17184 - catheter, angioplasty, balloon dilatation - it is used for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion and for post dilatation of coronary stents.

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

biotronik australia pty ltd - 60784 - cardiac radio-frequency ablation system - it is used for visualization of the contact force of an ablation catheter tip on the cardiac wall.

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

biotronik australia pty ltd - 47732 - angioplasty catheter, balloon dilatation, coronary, basic - pantera pro inflates at pressures as per compliance chart. radiopaque markers facilitate visualization & positioning (up to balloon ? 1.5 mm with only a single marker). two cath. of ??3.5mm are compatible for a kissing balloon procedure (guiding cath. inner ?1.78mm). there is a luer port for balloon in/deflation; working length is 140cm. shaft exit markers are located on the hypotube 92cm and 102cm (brachial & femoral technique) from the distal end of the pantera pro. pantera pro is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. the pantera pro (balloon diameter 2.0 ? 4.0mm) is also indicated for post-delivery expansion of balloon expandable stents.

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

biotronik australia pty ltd - 62551 - peripheral angioplasty balloon catheter, drug-eluting - passeo-18 lux is a peripheral transluminal angioplasty (pta) catheter for dilatation of stenotic segments in infrainguinal arteries with simultaneous local release of the antiproliferative ancillary substance (paclitaxel), which is delivered to the vessel wall upon inflation of the balloon. used to dilate de novo or restenotic lesions in the infrainguinal arteries.

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

biotronik australia pty ltd - 60106 - patient monitoring modem - it collects encoded data from an ipg/icd and transmits it wirelessly to a service centre via a mobile connection. the data is used for evaluation by a physician/technician for the patient?s care. used to automatically and continuously transmit data from an ipg/icd to a service centre. home monitoring is not an emergency system.

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

biotronik australia pty ltd - 60910 - coronary venous pacing lead - used for the permanent transvenous implantation in the coronary venous system via the coronary sinus in cardiac resynchronisation therapy as a component of an integrated system for long-term cardiac pacing together with a suitable implantable triple chamber pacemaker or lcd. conditional mr compatibility. used for permanent sensing and pacing for ventricular resynchronization.

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

biotronik australia pty ltd - 60910 - coronary venous pacing lead - used for the permanent transvenous implantation in the coronary venous system via the coronary sinus in cardiac resynchronisation therapy as a component of an integrated system for long-term cardiac pacing together with a suitable implantable triple chamber pacemaker or icd. conditional mr compatibility. used for permanent sensing and pacing for ventricular resynchronization.