DevicePMAs@therightstef:P010068_S009 JSONTXT 13 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 ds diagnostic/ablation deflectable 8mm tip catheter and is indicated for catheter-based atrial and ventricular electrophysiologic mapping (stimulation and recording), and when used with the stockert 70 radiofrequency generator (with software version 001/033 or higher) for the treatment of type i atrial flutter in patients 18 or older. The navistar rmt ds catheter provides location information when used with the carto rmt ep navigation system. The navistar rmt ds diagnostic/ablation steerable catheter is only for use with the stereotaxis magnetic navigation system (mns). Compatibility with the stereotaxis cardiodrive has not been determined.