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Approval for the phylax av icd system including the pulse generator, model number 122 382 and phylax av software cartridge swm 1000/i-gav. 2.u, model number 128 814. The device is indicated for use in patients who are at high risk of sudden death due to ventricular arrhythmias and have experienced one or more of the following situations: 1) survival of at least one episode of cardiac arrest (manifested by a loss of consciousness due to a ventricular tachyarrhythmia 2) recurrent, poorly tolerated sustained ventricular tachycardia (vt) note: the clinical outcome for hemodynamically stable, sustained-vt patients id not fully known. Safety and effectiveness studies for this indication have not been conducted.
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