Amvia Sky SR-T - Single-chamber pacemaker, rate-responsive - ARTG 443694
Access comprehensive regulatory information for Amvia Sky SR-T - Single-chamber pacemaker, rate-responsive in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 443694 and sponsored by Biotronik Australia Pty Ltd, manufactured by Biotronik SE & Co KG in Germany. The device registration started on March 13, 2024.
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Amvia Sky are implantable pacemakers (PM: SR-T and DR-T) and implantable cardiac resynchronization pacemakers (CRT-P: HF-T and HF-T QP). A pacemaker is part of an implantable pacemaker system comprising a pacemaker and leads. The primary function of the system is the ability, first, to sense the intrinsic heart rhythm/rate and, second, to provide pacing by electrical pulses of low energy, as well as to provide antitachycardia pacing by electrical pulses of low energy when necessary to ensure a stable heart rate or to support the intrinsic heart rate when needed. CRT-P systems share all mentioned functions and in addition provide permanent sensing and pacing of the left ventricle. The implantation of a pacemaker is a symptomatic therapy with the following objectives: • Sensing and recording the heart rhythm and automatically detecting bradycardia and atrial tachyarrhythmia (PMs and CRT-Ps). • Compensation of bradycardia through atrial or ventricular, or AV sequential pacing (PMs and CRT-Ps). • Physiological pacing (LBB(A)P) by stimulating the conduction system (PMs and CRT-Ps). • Termination of atrial tachycardia (AT/AF) through antitachycardia pacing (ATP) in the atrium (PMs and CRT-Ps). • Cardiac resynchronization through multisite ventricular pacing or through physiological pacing (CRT-Ps, e.g. biventricular pacing).