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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 NameCELSIUS RMT DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS, MODEL D-1249-02-S
Classification Namecatheter, electrode recording, or probe, electrode recording
Generic Nameradiofrequency ablation catheter, electrode recording catheter
Regulation Number870.1220
ApplicantBIOSENSE WEBSTER, INC.
PMA NumberP950005
Supplement NumberS018
Date Received09/28/2004
Decision Date12/16/2005
Product Code
DRF[ Registered Establishments with DRF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
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 celsius rmt diagnostic/ablation deflectable tip catheters 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.
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