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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 AND CELSIUS THERMOCOOL CATHETERS
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Generic Nameradiofrequency ablation catheter, electrode recording catheter
ApplicantBIOSENSE WEBSTER, INC.
PMA NumberP030031
Supplement NumberS002
Date Received09/16/2005
Decision Date05/05/2006
Product Code
OAD[ Registered Establishments with OAD ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at biosense webster, inc. , chihuahua, mexico.
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