DevicePMAs@therightstef:P960040_S036 JSONTXT 9 Projects

Approval for changes to the indications for use and clinical study section labeling. The devices are indicated for: for icds (ventak prx, mini, vitality, ventak av and prizm): guidant icds are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. For vitality avt: guidant vitality avt is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. This device is also intended to provide atrial antitachycardia pacing and atrial defibrillation treatment in patients who have or are at risk of developing atrial tachyarrhythmias. for crt-ds (contak cd and renewal):guidant cardiac resynchronization therapy defibrillators (crt-ds) are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. Guidant crt-ds are also indicated for reduction of symptoms of moderate to severe heart failure (nyha iii/iv) in patients who remain symptomatic despite stable, optimal heart failure drug therapy, and have left ventricular dysfunction (ef <= 35%) and qrs duration >= 120 ms.