|Trade Name||MEDTRONIC INSYNC III MARQUIS,MAXIMO & SENTRY|
|Classification Name||defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)|
|Generic Name||cardiac resynchronization therapy|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - specifications|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the medtronic insync iii marquis model 7279 with model 9989 application software, medtronic insync maximo models 7303 and 7304 with model 9998 application software, medtronic insync sentry models 7297 and 7299 with model 9998 application software. The devices are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. This system is also indicated for the reduction of the symptoms of moderate to severe heart failure (nyha functional class iii or iv) in those patients who remain symptomatic despite stable, optimal medical therapy and have a left ventricular ejection fraction <=35% and a prolonged qrs duration.