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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.
 
Trade NameNAVISTAR RMT DIAGNOSTIC/ABLATION STEERABLE TIP CATHETER
Classification Namecardiac ablation percutaneous catheter
Generic Nameradiofrequency ablation catheter, electrode recording catheter
ApplicantBIOSENSE WEBSTER, INC.
PMA NumberP990025
Supplement NumberS009
Date Received04/28/2005
Decision Date01/26/2006
Product Code
LPB[ Registered Establishments with LPB ]
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 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.
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