DevicePMAs@therightstef:P960040_S032 JSONTXT 11 Projects

Approval to enable the automatic intrinsic rhythm id algorithm update feature. The device, as modified, will be marketed under the trade name vitality vr/dr/vitality+ dr aicd systems and the programmer software application model 2857 version 1.6 and is indicated for use as follows: the vitality vr/dr/vitality+ dr aice system is indicated for use in patients who have had spontaneous and/or inducible life-threatening ventricular arrhythmias and those who are at high risk for developing such arrhythmias. In addition, this device is indicated for prophylactic treatment of patients with a prior myocardial infarction and ef <30%.