|Trade Name||INSYNC SENTRY MODEL 7297 ICD AND MODEL 9998 APPLICATION SOFTWARE VERSION 1.2|
|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 - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the insync sentry model 7297 icd and model 9998 application software version 1. 2. The device is indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The 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 ars duration >= 130ms.