|Trade Name||INSYNC II MARQUIS MODEL 7289 WITH MODEL 9989 APPLICATION SOFTWARE|
|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 - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the insync ii marquis model 7289 with model 9989 application software. The system as modified, will be marketed under the trade name insync ii marquis and 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 (as defined in the clinical trials section), and have a left ventricular ejection fraction less than or equal to 35 percent and a qrs duration greater than or equal to 130 ms.