DevicePMAs@therightstef:P950005_S010 JSONTXT 11 Projects

Approval for expanding the indications for use. The device, as modified, will be marketed under the trade name celsius diagnostic/ablation deflectable tip catheter and is indicated as follows: the biosense webster celsius diagnostic/ablation deflectable tip catheter and related accessories are indicated for catheter-based atrial and ventricular electrophysiological mapping and for use with compatible radiofrequency generators in adults and children 4 years of age and older in creating endocardial lesions during cardiac ablation procedures to treat arrhythmias.