|Trade Name||VITALITY AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS AND MODEL 2857 SOFTWARE, VERSION 1.6|
|Classification Name||implantable pulse generator, pacemaker (non-crt)|
|Generic Name||implantable pulse generator, pacemaker (non-crt)|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
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%.