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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 THERMOCOOL & CELSIUS THERMOCOOL DIAGNOSTIC/ABLATION CATHETERS
Classification Namecardiac ablation percutaneous catheter
Generic Nameradiofrequency ablation catheter, electrode recording catheter
ApplicantBIOSENSE WEBSTER, INC.
PMA NumberP030031
Supplement NumberS013
Date Received11/04/2008
Decision Date12/24/2008
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the labeling to incorporate results of the completed postmarket condition of approval study for the atrial flutter indication.
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