DevicePMAs@therightstef:P010012_S031 JSONTXT 11 Projects

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.