DevicePMAs@therightstef:P010068_S009
Annnotations
{"target":"https://pubannotation.org/docs/sourcedb/DevicePMAs@therightstef/sourceid/P010068_S009","sourcedb":"DevicePMAs@therightstef","sourceid":"P010068_S009","text":"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). 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