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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, electrode recording, or probe, electrode recording
Generic Nameradiofrequency ablation catheter, electrode recording catheter
Regulation Number870.1220
PMA NumberP950005
Supplement NumberS010
Date Received12/08/2000
Decision Date10/05/2001
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 celsius diagnostic/ablation deflectable tip catheter and is indicated as follows: the biosense webster celsius diagnostic/ablation deflectable tip catheter and related accessories are indicated for catheter-based atrial and ventricular electrophysiological mapping and for use with compatible radiofrequency generators in adults and children 4 years of age and older in creating endocardial lesions during cardiac ablation procedures to treat arrhythmias.