DevicePMAs@therightstef:P990025_S009 JSONTXT 11 Projects

Approval for adding remote magnetic navigation technology to the previously approved catheter. The device, as modified, will be marketed under the trade name navistar rmt diagnostic/ablation steerable tip catheter and is indicated for catheter-based atrial and ventricular electrophysiologic mapping and for use with the stereotaxis magnetic navigation system (mns) and compatible radiofrequency generators in adults and children four (4) years of age or older in creating endocardial lesions during cardiac ablation procedures to treat arrhythmias. When used with the cargo? ep navigation system, the navistar rmt catheter provides location information.