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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, NAVISTAR RMT THERMOCOOL, EZ STEER THERMOCOOL,CELSIUS RMT THERMOCOOL, THERMOCOOL
Generic NameCardiac ablation percutaneous catheter
ApplicantBIOSENSE WEBSTER, INC.
31 Technology Drive
Suite 200
Irvine, CA 92618
PMA NumberP030031
Supplement NumberS062
Date Received09/29/2014
Decision Date11/18/2014
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR CHANGES TO YOUR SOLDER IN ORDER TO COMPLY WITH THE EU ROHS DIRECTIVE.
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