Biventricular pacemaker/defibrillator
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
04-11-2017
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Available from:
Medtronic Australasia Pty Ltd
Class:
Class I
Manufactured by:
Medtronic Inc 710 Medtronic Parkway, Minneapolis, MN, 55432 United States Of America
Therapeutic area:
47270 - Biventricular pacemaker/defibrillator
Therapeutic indications:
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.
Authorization status:
A
Authorization date:
2016-10-18
