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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Applicant BIOSENSE WEBSTER, INC productcode LPB Center Devices Decision Date To 10/22/2016
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THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATIONAL ... BIOSENSE WEBSTER, INC. P030031 S065 03/18/2015
EZ STEER AND THERMOCOOL CATHETER FAMILIES BIOSENSE WEBSTER, INC. P030031 S066 03/19/2015
EZ STEER THERMOCOOL NAV, THERMOCOOL SF NAV BIOSENSE WEBSTER, INC. P030031 S067 03/23/2015
CATHETER, PERCUTANEOUS, CARDIAC ABLATION CELSIUS ... BIOSENSE WEBSTER, INC. P030031 S068 06/02/2015
THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CA... BIOSENSE WEBSTER, INC. P030031 S069 08/06/2015
THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION C... BIOSENSE WEBSTER, INC. P030031 S070 08/18/2015
CELSIUS THERMOCOOL, THERMOCOOL SF, NAVISTAR THERMO... BIOSENSE WEBSTER, INC. P030031 S071 11/05/2015
THERMOCOOL SMARTTOUCH SF UNI-DIRECTIONAL NAVIGATIO... BIOSENSE WEBSTER, INC. P030031 S072 08/11/2016
NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATIO... BIOSENSE WEBSTER, INC. P040036 08/11/2006
NAVISTAR THERMOCOOL CATHETER BIOSENSE WEBSTER, INC. P040036 S001 12/04/2006
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