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

medtronic australasia pty ltd - 47270 - biventricular pacemaker/defibrillator - the devices in this application are dual chamber, implantable cardioverter defibrillators with cardiac resynchronization therapy (crt-d). these multiprogrammable cardiac devices monitor and regulate the patient?s heart rate by providing single or dual chamber, rate-responsive bradycardia pacing; sequential biventricular pacing; ventricular tachyarrhythmia therapies; and atrial tachyarrhythmia therapies. the devices feature bluetooth wireless technology. lead connector: is4/df4 the medtronic cobalt hf quad crt-d mri surescan model dtpb2qq implantable cardiac resynchronization therapy defibrillator is indicated for use in patients who are at significant risk of developing life-threatening ventricular tachyarrhythmias and who have heart failure with ventricular arrhythmias. heart failure patients must have experienced one or more of the following conditions: ? ventricular dyssynchrony with prolonged qrs ? reduced ejection fraction (ef), regardless of new york heart association (nyha) class, if the patient is indicated for ventricular pacing and has high degree atrioventricular (av) block ? reduced ef with all the following characteristics: ? the patient received a conventional pacemaker or an implantable cardioverter defibrillator (icd). ? the patient subsequently developed worsening heart failure despite optimal medical therapy. ? the patient has a high proportion of right ventricular (rv) pacing

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

medtronic australasia pty ltd - 47270 - biventricular pacemaker/defibrillator - the devices in this application are dual chamber, implantable cardioverter defibrillators with cardiac resynchronization therapy (crt-d). these multiprogrammable cardiac devices monitor and regulate the patient?s heart rate by providing single or dual chamber, rate-responsive bradycardia pacing; sequential biventricular pacing; ventricular tachyarrhythmia therapies; and atrial tachyarrhythmia therapies. the devices feature bluetooth wireless technology. lead connector: is-1/df-1 the medtronic cobalt xt hf crt-d mri surescan model dtpa2d1 implantable cardiac resynchronization therapy defibrillator is indicated for use in patients who are at significant risk of developing life-threatening ventricular tachyarrhythmias and who have heart failure with ventricular arrhythmias. heart failure patients must have experienced one or more of the following conditions: ? ventricular dyssynchrony with prolonged qrs ? reduced ejection fraction (ef), regardless of new york heart association (nyha) class, if the patient is indicated for ventricular pacing and has high degree atrioventricular (av) block ? reduced ef with all the following characteristics: ? the patient received a conventional pacemaker or an implantable cardioverter defibrillator (icd). ? the patient subsequently developed worsening heart failure despite optimal medical therapy. ? the patient has a high proportion of right ventricular (rv) pacing

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

medtronic australasia pty ltd - 47270 - biventricular pacemaker/defibrillator - the devices in this application are dual chamber, implantable cardioverter defibrillators with cardiac resynchronization therapy (crt-d). these multiprogrammable cardiac devices monitor and regulate the patient?s heart rate by providing single or dual chamber, rate-responsive bradycardia pacing; sequential biventricular pacing; ventricular tachyarrhythmia therapies; and atrial tachyarrhythmia therapies. the devices feature bluetooth wireless technology. lead connector: is4/df4 the medtronic cobalt xt hf quad crt-d mri surescan model dtpa2qq implantable cardiac resynchronization therapy defibrillator is indicated for use in patients who are at significant risk of developing life-threatening ventricular tachyarrhythmias and who have heart failure with ventricular arrhythmias. heart failure patients must have experienced one or more of the following conditions: ? ventricular dyssynchrony with prolonged qrs ? reduced ejection fraction (ef), regardless of new york heart association (nyha) class, if the patient is indicated for ventricular pacing and has high degree atrioventricular (av) block ? reduced ef with all the following characteristics: ? the patient received a conventional pacemaker or an implantable cardioverter defibrillator (icd). ? the patient subsequently developed worsening heart failure despite optimal medical therapy. ? the patient has a high proportion of right ventricular (rv) pacing

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

medtronic australasia pty ltd - 47270 - biventricular pacemaker/defibrillator - the devices in this application are dual chamber, implantable cardioverter defibrillators with cardiac resynchronization therapy (crt-d). these multiprogrammable cardiac devices monitor and regulate the patient?s heart rate by providing single or dual chamber, rate-responsive bradycardia pacing; sequential biventricular pacing; ventricular tachyarrhythmia therapies; and atrial tachyarrhythmia therapies. the devices feature bluetooth wireless technology. lead connector type: is4/df4 the medtronic crome hf quad crt-d mri surescan model dtpc2qq implantable cardiac resynchronization therapy defibrillator is indicated for use in patients who are at significant risk of developing life-threatening ventricular tachyarrhythmias and who have heart failure with ventricular arrhythmias. heart failure patients must have experienced one or more of the following conditions: ? ventricular dyssynchrony with prolonged qrs ? reduced ejection fraction (ef), regardless of new york heart association (nyha) class, if the patient is indicated for ventricular pacing and has high degree atrioventricular (av) block ? reduced ef with all the following characteristics: ? the patient received a conventional pacemaker or an implantable cardioverter defibrillator (icd). ? the patient subsequently developed worsening heart failure despite optimal medical therapy. ? the patient has a high proportion of right ventricular (rv) pacing

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

medtronic australasia pty ltd - 47270 - biventricular pacemaker/defibrillator - the model dtpc2d4 dual chamber, implantable cardioverter defibrillator with cardiac resynchronization therapy (crt-d) is a multiprogrammable cardiac device that monitors and regulates the patient?s heart rate by providing single or dual chamber, rate-responsive bradycardia pacing; sequential biventricular pacing; ventricular tachyarrhythmia therapies; and atrial tachyarrhythmia therapies. this device features bluetooth wireless technology. lead connector: is-1/df-4. the medtronic crome hf crt-d mri surescan model dtpc2d4 implantable cardiac resynchronization therapy defibrillator is indicated for use in patients who are at significant risk of developing life-threatening ventricular tachyarrhythmias and who have heart failure with ventricular arrhythmias. heart failure patients must have experienced one or more of the following conditions: ? ventricular dyssynchrony with prolonged qrs ? reduced ejection fraction (ef), regardless of new york heart association (nyha) class, if the patient is indicated for ventricular pacing and has high degree atrioventricular (av) block ? reduced ef with all the following characteristics: ? the patient received a conventional pacemaker or an implantable cardioverter defibrillator (icd). ? the patient subsequently developed worsening heart failure despite optimal medical therapy. ? the patient has a high proportion of right ventricular (rv) pacing

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

medtronic australasia pty ltd - 32585 - catheter, neurological, ventricular - the ventricular catheter with bioglide has an interior and exterior hydrophilic surface modification for enhanced lubricity and ease of insertion. the catheter is fabricated of translucent silicone elastomer tubing with a radiopaque stripe, and is resistant to catheter kinking and compression. a right angle clip is packaged with each catheter. a stainless steel stylet is packaged with each catheter. a flexible tube that is surgically inserted through the skull and brain to access the cerebrospinal fluid-filled cavities of the brain (ventricles). this device is single-use.

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

medtronic australasia pty ltd - 32585 - catheter, neurological, ventricular - medtronic's ventricular, barium impregnated catheters are completely radiopaque. each of the catheters is kink and compression resistant, imprinted with length markers, and is packaged with a stainless steel stylet. they are designed for use as proximal components of csf flow control shunts for use in shunting cerebrospinal fluid from the ventricles of the brain. a flexible tube the is surgically inserted through the skull and brain to access the cerebrospinal fluid-filled cavities of the brain (ventricles). this device is single use.

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

medtronic australasia pty ltd - 47270 - biventricular pacemaker/defibrillator - the amplia mri quad system is indicated for use in patients who are at high risk of sudden death due to ventricular tachyarrhythmias and who have heart failure with ventricular dyssynchrony. the device is intended to provide atrial and/or ventricular antitachycardia pacing, cardioversion, and defibrillation for automated treatment of atrial and/or life-threatening ventricular tachyarrhythmias.

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

b braun australia pty ltd - 10704 - catheter, cerebrospinal - the ventricular catheter is used for draining cerebrospinal fluid (csf) from the ventricles into an appropriate cavity. ? the catheters are radio opaque silicon catheters with graduated marking and an introducing stylet.the graduations of ventricular catheter start from the tip. markings are at 30mm (3), 50mm (5) 70mm (7), 100mm (10) and 130mm (13). ? treatment of hydrocephalus to remove, drain or transfer cerebrospinal fluid from the central nervous system.

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

medtronic australasia pty ltd - 33923 - port/catheter, internal, subcutaneous - the ventricular ports are designed to provide percutaneous access to the ventricular cerebrospinal fluid (csf) through a port connected to a ventricular catheter. the ports are designed to provide efficient fluid delivery and withstand repeated needle punctures. the system provides access to the lateral cerebral ventricles or to cystic tumours and similar, via puncture for the injection of drugs. ports are useful in obtaining csf samples studies, for monitoring pressure, and for drainage. a short- or long-term implantable device composed of a portal with septum, connected to a catheter, used for the delivery of drugs or other fluids to various anatomical regions or vessels. the device is implanted under the skin.