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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceNAVISTAR THERMOCOOL AND CELSIUS THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER
Generic NameCardiac ablation percutaneous catheter
ApplicantBiosense Webster, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP040036
Supplement NumberS002
Date Received12/01/2006
Decision Date04/23/2007
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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