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

biotronik australia pty ltd - 17846 - catheter, intravascular, guiding - the inner guiding catheter is made from braid reinforced pebax and polyamide 12 with inner hydrophilic coating. the inner along with the outer catheter jointly form a telescope system. the proximal handle has a fully integrated slittable haemostatic valve and a luer-lock connection. used to sub-select target veins and as a conduit to guide devices or to deliver contrast medium, into specific branches or the coronary venous system and used too directly deliver leads with a diameter less the 5f. in conjunction with the selectra accessory kit, selectra guiding catheters are used to facilitate lead implantation in the heart chambers or in the coronary veins via the coronary sinus.

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

biotronik australia pty ltd - 47263 - biventricular pacemaker - evity 8 hf-t qp 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; is4 compatible; home monitoring. promri? labelled , are conditionally safe for use in the mri environment (mr conditional). evity 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 ?additional triple-chamber features: resynchronization of ventricular chamber contraction via biventricular pacing

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

biotronik australia pty ltd - 47263 - biventricular pacemaker - edora 8 hf-t qp 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; is4 compatible; home monitoring. promri? labelled , 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, ventricular, or av sequential pacing ?additional triple-chamber features: resynchronization of ventricular chamber contraction via biventricular pacing

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

biotronik australia pty ltd - 47263 - biventricular pacemaker - evity 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. promri? labelled , are conditionally safe for use in the mri environment (mr conditional). evity 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 ? additional triple-chamber features: resynchronization of ventricular chamber contraction via biventricular pacing

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

biotronik australia pty ltd - 47263 - biventricular pacemaker - edora 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. promri? labelled , 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, ventricular, or av sequential pacing ?additional triple-chamber features: resynchronization of ventricular chamber contraction via biventricular pacing

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

biotronik australia pty ltd - 47265 - dual-chamber pacemaker, rate-responsive - evity 6 dr-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, dual chamber, rate adaptive, unipolar/bipolar, is-1 compatible, with home monitoring. promri? labelled (mr conditional) pacemakers are conditionally safe for use in the mri environment. evity 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

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

biotronik australia pty ltd - 47265 - dual-chamber pacemaker, rate-responsive - evity 8 dr-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, dual chamber, rate adaptive, unipolar/bipolar, is-1 compatible, with home monitoring. promri? labelled (mr conditional) pacemakers are conditionally safe for use in the mri environment. evity 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

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

biotronik australia pty ltd - 47265 - dual-chamber pacemaker, rate-responsive - edora 8 dr-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, dual chamber, rate adaptive, unipolar/bipolar, is-1 compatible, with home monitoring. promri? labelled (mr conditional) pacemakers are conditionally safe for use in the mri environment. 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, ventricular, or av sequential pacing

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

biotronik australia pty ltd - 47267 - single-chamber pacemaker, rate-responsive - evity 6 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 (mr conditional) pacemakers are conditionally safe for use in the mri environment. evity 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 - 47267 - single-chamber pacemaker, rate-responsive - evity 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 (mr conditional) pacemakers are conditionally safe for use in the mri environment. evity 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