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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 Decision Date To 07/29/2014
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EZ STEER BIOSENSE WEBSTER, INC. P030031 S057 10/09/2013
CELCIUS/ RMT THERMOCOOL ,NAVISTAR THERMOCOOL ,NAVI... BIOSENSE WEBSTER, INC. P030031 S058 01/24/2014
CELSIUS RMT THERMOCCOL CAT, CELSIUS THERMOCCOL CAT... BIOSENSE WEBSTER, INC. P030031 S059 12/17/2015
THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION C... BIOSENSE WEBSTER, INC. P030031 S060 09/12/2014
THERMO-COOL SF (BI-DIRECTIONAL AND UNI-DIRECTIONAL... BIOSENSE WEBSTER, INC. P030031 S061 10/15/2014
NAVISTAR THERMOCOOL, CELSIUS THERMOCOOL, NAVISTAR ... BIOSENSE WEBSTER, INC. P030031 S062 11/18/2014
THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CA... BIOSENSE WEBSTER, INC. P030031 S063 11/19/2014
NAVISTAR THERMOCOOL ELECTROPHYSIOLOGY CATHETER, CE... BIOSENSE WEBSTER, INC. P030031 S064 12/08/2014
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
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