|Approval Order Statement |
Approval for modifications to the epic+ icds to include higher energy output, software modifications, and a different header type. The device, as modified, will be marketed under the trade name atlas+ dr/vr implantable cardioverter defibrillators, models v-242, v-243, v-193 and v-193c, epic+ models v-233, v-239 and v196, and model 3307 v. 4. 5a software, and is intended 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 indications.