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

smith & nephew pty ltd - 44742 - prosthetic joint implantation kit - for cutting and forming bone to allow the implantation of a joint prosthesis

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

medtronic australasia pty ltd - 61680 - implantable cardiac device management application software - an application software program intended to be used in the management of an implantable cardiac device (e.g., monitor,pulse generator, pacemaker, defibrillator) by enabling computer assisted functionality typically in one or more of the following areas: device programming; device function analysis; data extraction, storage, analysis and/or transfer; and clinical consultation/intervention planning. depending on the functionality, it can run on dedicated hardware, an off the shelf computer (e.g., tablet, smartphone), or webbased servers.

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

medtronic australasia pty ltd - 61126 - implantable pulse generator mesh bag, bioabsorbable - the envelope is intended to hold a pacemaker pulse generator or defibrillator securely in order to provide a stable environment when implanted in the body. the envelope contains the ancillary medicinal substances rifampicin and minocycline, which have been shown to reduce infection in an in vivo model of bacterial challenge following surgical implantation of the generator or defibrillator. the envelope is only intended to be used in conjunction with pacemakers and implantable defibrillators.

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

corin australia pty ltd - 63998 - implantable orthopaedic fixation device connection screw - a small implantable surgical device designed to be used as a fixation point/screw between two implantable components during an orthopaedic procedure.

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

boston scientific pty ltd - 57996 - implantable stimulator control magnet - the external magnet is used to turn an implantable pulse generator (ipg) on.

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

biotronik australia pty ltd - 57996 - implantable stimulator control magnet - neuro m50 magnet is used to pair the stimulators with the clinician programmer or the patient programmer. when the magnet is placed on the stimulator, the stimulator enters a mode that enables the communication. when the magnet is placed on the stimulator for longer than 60 s, the stimulation therapy is suspended. neuro m50 magnet is part of the prospera spinal cord stimulation (scs) system, which is designed to manage chronic pain by delivering electrical impulses to nerve structures in and around the spinal cord. the implantable stimulator is intended to be used with compatible leads and associated accessories. the scs system is intended to be implanted and managed by healthcare professionals familiar with the use of neurostimulation devices.

European Union - English - EMA (European Medicines Agency)

dipharma arzneimittel gmbh - miglustat - gaucher disease - other alimentary tract and metabolism products - miglustat dipharma is indicated for the oral treatment of adult patients with mild to moderate type 1 gaucher disease.miglustat dipharma may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable.miglustat dipharma is indicated for the treatment of progressive neurological manifestations in adult patients and paediatric patients with niemann-pick type c disease.

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

biotronik australia pty ltd - 37265 - defibrillator, implantable, automatic, dual-chamber - a dual chamber, rate adaptive icd with home monitoring functions, max. shock energy 40j and df4/is-1 connector. biocompatible titanium housing is hermetically sealed and serves as a potential antipole during shock delivery or in the case of unipolar lead configuration. ellipsoid shape facilitates implantation in the pectoral muscle area. the connections for bipolar pacing, sensing and shock delivery are found in the header. mr conditional. rivacor 7 dr-t belongs to a family of implantable cardioverter-defibrillators (icds). the primary objective of the therapy is to prevent sudden cardiac death. furthermore, the device is capable of treating bradycardia arrhythmias. the implantation of an icd is a symptomatic therapy with the following objectives: ?termination of spontaneous ventricular fibrillation (vf) through shock delivery ?termination of spontaneous ventricular tachycardia (vt) through antitachycardia pacing (atp); in case of ineffective atp or hemodynamically not tolerated vts, with shock delivery ?comp

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

biotronik australia pty ltd - 37265 - defibrillator, implantable, automatic, dual-chamber - a dual chamber, rate adaptive icd with home monitoring functions, max. shock energy 40j and df4/is-1 connector. biocompatible titanium housing is hermetically sealed and serves as a potential antipole during shock delivery or in the case of unipolar lead configuration. ellipsoid shape facilitates implantation in the pectoral muscle area. the connections for bipolar pacing, sensing and shock delivery are found in the header. mr conditional. rivacor 5 dr-t belongs to a family of implantable cardioverter-defibrillators (icds). the primary objective of the therapy is to prevent sudden cardiac death. furthermore, the device is capable of treating bradycardia arrhythmias. the implantation of an icd is a symptomatic therapy with the following objectives: ?termination of spontaneous ventricular fibrillation (vf) through shock delivery ?termination of spontaneous ventricular tachycardia (vt) through antitachycardia pacing (atp); in case of ineffective atp or hemodynamically not tolerated vts, with shock delivery ?comp

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

biotronik australia pty ltd - 35852 - defibrillator, implantable, automatic - a single chamber, rate adaptive icd with home monitoring functions, max. shock energy 40j and df4/is-1 connector. biocompatible titanium housing is hermetically sealed and serves as a potential antipole during shock delivery or in the case of unipolar lead configuration. ellipsoid shape facilitates implantation in the pectoral muscle area. the connections for bipolar pacing, sensing and shock delivery are in the header. dx functionality also senses in the right atrium. mr conditional. rivacor 7 vr-t dx belongs to a family of implantable cardioverter-defibrillators (icd). the primary objective of the therapy is to prevent sudden cardiac death. furthermore, the device is capable of treating bradycardia arrhythmias with ventricular pacing. the implantation of an icd is a symptomatic therapy with the following objectives: ?termination of spontaneous ventricular fibrillation (vf) through shock delivery ?termination of spontaneous ventricular tachycardia (vt) through antitachycardia pacing (atp); in case of ineffec