Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

biotronik australia pty ltd - 36106 - pacemaker system analyser, invasive - the psa module is an expansion module for the renamic programmer and is used during implantation and follow-up of implantable pacemakers and icds (implantable cardioverter-defibrillators). renamic is equipped with a slot for insertion of the module. psa module for the renamic programmer evaluates the position and integrity of leads,& determination of appropriate pacing parameters for appropriate biotronik implanted devices (pacemaker/ icd).

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

biotronik australia pty ltd - 33968 - screwdriver, surgical - the torque wrench with torque control is intended for connecting biotronik leads and accessories to the is-1 and df-1 connectors of biotronik's implantable active devices (e.g. cardiac pacemakers, icds).

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

biotronik australia pty ltd - 10598 - catheterization kit, cardiac - the selectra accessory kit is with the lead implantation system and includes: a slitter tool used to remove both the guide catheter and inner sub-selecting catheter by slitting away after implantation: a guide wire that used to guide the introduction of the catheters into the right atrium. the kit also includes a transvalvular insertion tool to facilitate introduction of guidewires, syringe, guide wire torque, check-valve, stop cock and sealing caps. 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.

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

biotronik australia pty ltd - 17846 - catheter, intravascular, guiding - the outer guiding catheter is made from braid reinforced pebax (polyetherblockamide) and polyamide 12 with inner hydrophilic coating. the outer along with the inner catheter jointly form a telelescope system. the catheter proximal handle contains a fully integrated slittable hemostatic valve that avoids excessive bleeding and allows ease of use reducing the risk of lead dislodgement and an infusion port to allow for flushing / injection of contrast media. supplied with a dilator. 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.

Avstralija - angleščina - 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.

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

biotronik australia pty ltd - 13833 - stylet, - stylets are intended for use in longterm implantable biotronik leads and are applied during the implantation procedure. stylets predominantly serve to stiffen the flexible lead during implantation in order to facilitate its positioning.

Avstralija - angleščina - 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

Avstralija - angleščina - 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

Avstralija - angleščina - 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

Avstralija - angleščina - 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