DevicePMAs@therightstef:P060027_S000 JSONTXT 11 Projects

Approval for the ovatio crt-d system. the ovatio crt-d is indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias. the device is also indicated for the reduction of heart failure symptoms in medically optimized nyha functional class iii and iv patients with left ventricular ejection fraction of 35% or less, and a qrs duration of 150 ms or longer. situs otw lv lead is designed to pace the left ventricle through a coronary vein. it is intended to be used in conjunction with ela medical cardiac synchronization therapy pulse generators.