DevicePMAs@therightstef:P960040_S025 JSONTXT 11 Projects

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).