Approval Order Statement
Approval for the medtronic(r) model 7271 gem(tm) dr dual chamber implantable cardioverter defibrillator system with mdoel 9960 (gem(tm) dr) application software, medtronic(r) model 6940 capsurefix(r) lead and model 9466 patient magnet. This system is indicated for use in patients who are at risk of sudden death due to ventricular arrhythmias and have experienced one of the following situations: survival of at least one episode of cardiac arrest (manifested by loss of consciousness) due to ventricular tachyarrhythmia or recurrent, poorly tolerated, sustained ventricular tachycardia. (note: the clinical outcome for hemodynamically stable vt patients is not fully known. Safety and effectiveness studies have not been conducted. ). |
