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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.
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