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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 DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER
Classification Namecardiac ablation percutaneous catheter
Generic Namedrf(21 cfr 870.1220)
ApplicantBIOSENSE WEBSTER, INC.
PMA NumberP040036
Supplement NumberS002
Date Received12/01/2006
Decision Date04/23/2007
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for merging the labeling for the two approved indications for the navistar thermocool diagnostic/ablation catheters (atrial flutter under p030031, and ventricular tachycardia under p040036) and updating the labeling for the celsius thermocool which remains approved for treatment of atrial flutter only.
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