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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 RMT THERMOCOOL CATHETER
Generic NameCardiac ablation percutaneous catheter
ApplicantBIOSENSE WEBSTER, INC.
31 Technology Drive
Suite 200
Irvine, CA 92618
PMA NumberP030031
Supplement NumberS024
Date Received01/14/2010
Decision Date06/28/2010
Product Code LPB 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR A TEST METHOD CHANGE FOR THE FINAL INSPECTION FLOW AND LEAK TEST.
Post-Approval StudyShow Report Schedule and Study Progress
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