|Trade Name||INSYNC III MODEL 8042 AND INSYNC III MODEL 9981 APPLICATION SOFTWARE|
|Classification Name||implantable pulse generator, pacemaker (non-crt)|
|Generic Name||implantable pacemaker pulse generator|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the insync iii model 8042 and insync iii model 9981 application software which is indicated as follows: the insync iii model 8042 device is indicated for the reduction of symptoms of moderate to severe heart failure (nyha 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 <=35%, and a qrs >=130 ms. Rate adaptive pacing is provided for those patients developing a bradycardia indication who might benefit from increased pacing rates concurrent with increase in activity. Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of av synchrony.