|Trade Name||VENTAK VITALITY AVT AICD, MODELS A135 AND A155, MODEL 2920 PROGRAMMER WITH MODEL 2812 APPLICATION SOFTWARE VERSION 1.2|
|Classification Name||implantable pulse generator, pacemaker (non-crt)|
|Generic Name||implantable pulse generator, pacemaker (non-crt)|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a fast-charge version of the device (model a155) and to correct software anomalies (models a155 and a135). The device, as modified, will be marketed under the trade name ventak vitality avt aicd system and is indicated as follows: the vitality avt aicd system is indicated for use in patients who are icd indicated and who have atrial tachyarrhythmias or who are at risk of developing atrial tachyarrhythmias. Patient populations who are indicated for a guidant icd include those who have had spontaneous and/or inducible life-threatening ventricular arrhythmias and those who are at high risk for developing such arrhythmias; or, patients who may benefit from prophylactic treatment due to a prior myocardial infarction and an ejection fraction <=30%.