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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 & CELSIUS THERMOCOOL DIAGNOSTIC/ABLATION CATHETERS
Generic NameCardiac ablation percutaneous catheter
ApplicantBiosense Webster, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP030031
Supplement NumberS013
Date Received11/04/2008
Decision Date12/24/2008
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
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 CHANGES TO THE LABELING TO INCORPORATE RESULTS OF THE COMPLETED POSTMARKET CONDITION OF APPROVAL STUDY FOR THE ATRIAL FLUTTER INDICATION.
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