|Trade Name||CONTAK RENEWAL 3 RF/HE CRT-D,CONSULT PROGRAMMER SOFT WARE|
|Classification Name||implantable pulse generator, pacemaker (non-crt)|
|Generic Name||device resynchronization therapy-defibrillator (crt-d) system|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the addition of wandless telemetry to your currently market-approved crt-d devices that will allow communication with the programmer at an increased distance. The device, as modified, will be marketed under the trade name contak renewal 3 rf and is indicated for the following: the contak renewal 3 rf crt-d is indicated for patients with moderate to severe heart failure (nyha iii/iv) who remain symptomatic despite stable, optimal heart failure drug therapy, and have left ventricular dysfunction (ef <= 35%) and qrs duration >= 120 ms.