DevicePMAs@therightstef:P910023_S065 JSONTXT 11 Projects

Approval for the epic plus dr/vr device with model 3307 version 4.3a programmer software. The device, as modified, will be marketed under the trade name st. jude medical epic plus vr/dr implantable cardioverter defibrillators (models v-196 and v-236) and is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. Af suppression pacing is indicated for suppression of paroxysmal or persistent atrial fibrillation in patients with the above icd indication and sinus node dysfunction. The programmer software model 3307 version 4.3a supports st. jude medical's bradycardia and tachycardia pulse generators.