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

boston scientific pty ltd - 38141 - cardiac output unit, software - the automated screening tool provides information to help the clinician determine whether or not the patient is a viable candidate for an s-icd system. the automated screening tool is intended to aid the workflow associated with screening patients.

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

boston scientific pty ltd - 35223 - lead, pacemaker, implantable, endocardial - the fineline ii sterox leads are bipolar endocardial pacing leads designed for use with implantable pulse generators for long-term cardiac pacing. a silicone rubber collar at the distal tip contains 0.75mg of dexamethasone acetate. each lead is composed of two coated conductor wires wound together to form a single conductor coil. the lead includes a polyurethane outer insulation and fixation is achieved by silicone rubber tines. the lead is intended for chronic pacing and sensing of the atrium when used with a compatible pulse generator.

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

boston scientific pty ltd - 47267 - single-chamber pacemaker, rate-responsive - this pulse generator provides bradycardia pacing and adaptive rate pacing to detect and treat bradyarrhythmias. the pulse generator has independently programmable outputs and accepts one or more of the following leads, depending on the model: ? one is-1 unipolar or bipolar atrial lead ? one is-1 unipolar or bipolar right ventricular lead? device includes zip telemetry. connector type ra/ rv: is-1. case is hermetically sealed titanium. supplied with a torque wrench boston scientific pacemakers are indicated for treatment of the following conditions: ? symptomatic paroxysmal or permanent second- or third-degree av block ? symptomatic bilateral bundle branch block ? symptomatic paroxysmal or transient sinus node dysfunction with or without associated av conduction disorders (i.e., sinus bradycardia, sinus arrest, sinoatrial [sa] block) ? bradycardia-tachycardia syndrome, to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias ? neurovascular (vaso-vagal) syndromes or hypersensitive caro

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

boston scientific pty ltd - 47265 - dual-chamber pacemaker, rate-responsive - this pulse generator provides bradycardia pacing and adaptive rate pacing to detect and treat bradyarrhythmias. the pulse generator has independently programmable outputs and accepts one or more of the following leads, depending on the model: ? one is-1 unipolar or bipolar atrial lead ? one is-1 unipolar or bipolar right ventricular lead? device includes zip telemetry. connector type ra: is-1, rv: is-1. case is hermetically sealed titanium. supplied with a torque wrench boston scientific pacemakers are indicated for treatment of the following conditions: ? symptomatic paroxysmal or permanent second- or third-degree av block ? symptomatic bilateral bundle branch block ? symptomatic paroxysmal or transient sinus node dysfunction with or without associated av conduction disorders (i.e., sinus bradycardia, sinus arrest, sinoatrial [sa] block) ? bradycardia-tachycardia syndrome, to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias ? neurovascular (vaso-vagal) syndromes or hypersensitiv

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

boston scientific pty ltd - 47265 - dual-chamber pacemaker, rate-responsive - this pulse generator provides bradycardia pacing and adaptive rate pacing to detect and treat bradyarrhythmias. the pulse generator has independently programmable outputs and accepts one or more of the following leads, depending on the model: ? one is-1 unipolar or bipolar atrial lead ? one is-1 unipolar or bipolar right ventricular lead? device includes zip telemetry. connector type ra: is-1, rv: is-1. case is hermetically sealed titanium. supplied with a torque wrench boston scientific pacemakers are indicated for treatment of the following conditions: ? symptomatic paroxysmal or permanent second- or third-degree av block ? symptomatic bilateral bundle branch block ? symptomatic paroxysmal or transient sinus node dysfunction with or without associated av conduction disorders (i.e., sinus bradycardia, sinus arrest, sinoatrial [sa] block) ? bradycardia-tachycardia syndrome, to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias ? neurovascular (vaso-vagal) syndromes or hypersensitiv

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

boston scientific pty ltd - 47263 - biventricular pacemaker - this pulse generator provides a variety of therapies, including cardiac resynchronization therapy (crt), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation and bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias. device includes zip telemetry. connector type ra: is-1, rv: is-1, lv: is4. case is hermetically sealed titanium. supplied with a torque wrench. boston scientific cardiac resynchronization therapy pacemakers (crt-ps) are indicated for patients who have symptomatic congestive heart failure including left ventricular dysfunction and wide qrs; and/or one or more of the following conditions: ? symptomatic paroxysmal or permanent second- or third-degree av block ? symptomatic bilateral bundle branch block ? symptomatic paroxysmal or transient sinus node dysfunction with or without associated av conduction disorders (i.e., sinus bradycardia, sinus arrest, sinoatrial [sa] block) ? bradycardia-tachycardia syn

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

boston scientific pty ltd - 47263 - biventricular pacemaker - this pulse generator provides a variety of therapies, including cardiac resynchronization therapy (crt), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation and bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias. device includes zip telemetry. connector type ra: is-1, rv: is-1, lv: lv-1. case is hermetically sealed titanium. supplied with a torque wrench. boston scientific cardiac resynchronization therapy pacemakers (crt-ps) are indicated for patients who have symptomatic congestive heart failure including left ventricular dysfunction and wide qrs; and/or one or more of the following conditions: ? symptomatic paroxysmal or permanent second- or third-degree av block ? symptomatic bilateral bundle branch block ? symptomatic paroxysmal or transient sinus node dysfunction with or without associated av conduction disorders (i.e., sinus bradycardia, sinus arrest, sinoatrial [sa] block) ? bradycardia-tachycardia sy

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

boston scientific pty ltd - 47263 - biventricular pacemaker - this pulse generator provides a variety of therapies, including cardiac resynchronization therapy (crt), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation and bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias. device includes zip telemetry. connector type ra: is-1, rv: is-1, lv: is-1. case is hermetically sealed titanium. supplied with a torque wrench. boston scientic cardiac resynchronization therapy pacemakers (crt-ps) are indicated for patients who have symptomatic congestive heart failure including left ventricular dysfunction and wide qrs; and/or one or more of the following conditions: ? symptomatic paroxysmal or permanent second- or third-degree av block ? symptomatic bilateral bundle branch block ? symptomatic paroxysmal or transient sinus node dysfunction with or without associated av conduction disorders (i.e., sinus bradycardia, sinus arrest, sinoatrial [sa] block) ? bradycardia-tachycardia synd

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

boston scientific pty ltd - 35223 - lead, pacemaker, implantable, endocardial - endocardial pace/sense lead?intended for chronic bipolar pacing and sensing in the atrium and/or ventricle. leads have a is-1 bipolar to be used in conjunction with a compatible cardiac device. leads are mr conditional when connected to boston scientific mr conditional pulse generators. steroid-eluting?upon exposure to body fluids, the steroid elutes from the lead to help reduce tissue inflammation response at the distal electrode. intended for chronic pacing and sensing in the right atrium and/or right ventricle when used with a compatible pulse generator

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

boston scientific pty ltd - 35223 - lead, pacemaker, implantable, endocardial - endocardial pace/sense lead?intended for chronic bipolar pacing and sensing in the atrium and/or ventricle. leads have a is-1 bipolar to be used in conjunction with a compatible cardiac device. leads are mr conditional when connected to boston scientific mr conditional pulse generators. steroid-eluting?upon exposure to body fluids, the steroid elutes from the lead to help reduce tissue inflammation response at the distal electrode. intended for chronic pacing and sensing in the right atrium (preformed atrial j) or right ventricle (straight) when used with a compatible pulse generator