|Trade Name||MEDTRONIC INSYNC 11 PROTECT MODEL 7295 WITH THE MODEL 9992 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 - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the medtronic insync ii protect model 7295 with model 9992 application software. The device, as modified, will be marketed under the trade name medtronic insync ii protect model 7295 with model 9992 application software and is indicated as follows: the insync ii protect provides 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 qrs duration >= 130 ms. The insync ii protect device only allows arrhythmias in the vf zone to receive treatment. Arrhythmias in the monitor only zone will not be treated by the device.