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Approval for the teligen implantable cardioverter defibrillator models e102 and e110, the cognis cardiac resynchronization therapy defibrillator (crt-d) models n118 and n119, application software model 2868, rev. 1.01 and the model 6628 torque wrench. The device, as modified, will be marketed under the trade name teligen implantable cardioverter defibrillator models e102 and e110, the cognis cardiac resynchronization therapy defibrillator (crt-d) models n118 and n119, application software model 2868, rev. 1.01 and the model 6628 torque wrench. The cognis crt-d devices are indicated for patients with moderate-to-severe heart failure (nyha iii/iv) who remain symptomatic despite stable, optimal failure drug therapy, and have left ventricular (lv) dysfunction (ejection fraction <=35%) and qrs duration >=120 ms. the teligen devices are intended to provide ventricular antitachycardia pacing (atp) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
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