DevicePMAs@therightstef:P960040_S039 JSONTXT 10 Projects

Approval for the vitality 2 icd system (models t165, t167, t175, t177), model 2857 application software (version 2.2), and quick profiles disk (model 2828 version 1.0). The device is indicated for use in the following: guidant icds are intended to provide therapy for the automated treatment oflife-threatening ventricular arrhythmias. patient populations who are indicated for a guidant icd 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 of <= 30%.