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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
3333 diamond canyon rd.
diamond bar, CA 91765
PMA NumberP010068
Supplement NumberS009
Date Received01/31/2006
Decision Date03/21/2007
Product Code
OAD[ Registered Establishments with OAD ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
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.