|Trade Name||VITALITY AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS|
|Classification Name||implantable pulse generator, pacemaker (non-crt)|
|Generic Name||implantable cardioverter defibrillator|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for vitality automatic implantable cardioverter defibrillator (aicd) systems (vitality dr model 1871, vitality vr model 1870 and vitality + dr model 1872), and model 2857 software, version 1. 5. The device is indicated for use in the following: the vitality aicd system is intended to provide therapy for the automated treatment of life threatening ventricular arrhythmias. Patient populations who are indicated for a guidant aicd include: 1) those who have had spontaneous and/or inducible life-threatening ventricular arrhythmias and those who are at high risk for developing such arrhythmias, or 2) patients who may benefit from prophylactic treatment due to a prior myocardial infarction and an ejection fraction <= 30% (as defined in the madit ii clinical study appendix).