|Trade Name||INSYNC III BIVENTRICULAR PACING SYSTEM (MODEL 8041)|
|Classification Name||implantable pulse generator, pacemaker (non-crt)|
|Supplement Type||normal 180 day track|
|Supplement Reason|| labeling change - performance characteristics|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for modifications to the device labeling to describe the care-hf clinical study. Medtronic also requests a reformatting of the indications statement and the addition of a clinical outcomes section to the device labeling which includes claims based on the primary endpoint and two secondary endpoints in the care-hf study. The medtronic insync iii model 8042 is indicated for nyha functional class iii and iv 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 prolonged qrs duration. Rate adaptive pacing is provided for those patients developing a bradycardia indication who might benefit from increased pacing rates concurrent with increases in activity. Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of av synchrony.