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Approval for incepta, energen. punctua and teligen icd models and the incepta, energen. punctua and cognis crt-d models and prm software application model 2868 and pulse generator software. the devices as modified will be marketed under the trade names incepta, energen, punctua, teligen and cognis icd and crt-d models and are indicated to provide ventricular antitachycardia pacing (atp) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmiasor for patients with heart failure who receive stable optimal pharmacological therapy: moderate to severe heart failure (nyha class i1i-iv) with ef <= 35% and qrs duration >= 120 ms and left bundle branch block (lbbb) with qrs >= 130 ms, ef <= 30%, and mild (nyha class ii) ischemic or nonischemic heart failure or asymptomatic (nyha class 1) ischemic heart failure.
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