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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.
 
DeviceTHERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER
Generic NameCardiac ablation percutaneous catheter
ApplicantBIOSENSE WEBSTER, INC.
31 Technology Drive
Suite 200
Irvine, CA 92618
PMA NumberP040036
Supplement NumberS056
Date Received06/28/2016
Decision Date07/18/2016
Product Code LPB 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Use of new equipment, the Output Control System, to inspect connectivity of force and navigation sensor coils, the data on the device EEPROM, and compare EEPROM information as well as physical attributes against the Work Order Packet Requirements.
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