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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 DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETER
Classification Namecatheter, electrode recording, or probe, electrode recording
Generic Nameradiofrequency ablation catheter, electrode recording catheter
Regulation Number870.1220
ApplicantBIOSENSE WEBSTER, INC.
PMA NumberP990025
Supplement NumberS002
Date Received12/11/2000
Decision Date09/26/2001
Product Code
DRF[ Registered Establishments with DRF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for expanding the indications for use. The device, as modified, will be marketed under the trade name navistart deflectable tip diagnostic/ablation catheter and is indicated a follows: the biosense webster navi-star diagnostic/ablation catheter, and related accessory devices are indicated for catheter-based atrial and ventricular electrophysiological mapping, and for use with a compatible rf generator in adults and children 4 years of age and older in creating endocardial lesions during cardiac ablation procedures to treat arrhythmias. When used with the carto ep navigation system, the navi-star diagnostic/ablation catheter provides location information.
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