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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 08/05/2015
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EZ STEER THERMOCOOL NAV BIOSENSE WEBSTER, INC. P040036 S038 08/22/2013
NAVISTAR THERMOCOOL CATHETER,NAVISTAR RMT THERMOCO... BIOSENSE WEBSTER, INC. P040036 S039 09/05/2013
THERMOCOOL SF BIOSENSE WEBSTER, INC. P040036 S040 10/09/2013
NAVISTAR THERMOCOOL CATHETER,NAVISTAR RMT THERMOCO... BIOSENSE WEBSTER, INC. P040036 S041 01/24/2014
NAVISTAR THERMOCOOL BIOSENSE WEBSTER, INC. P040036 S043 08/01/2014
EZ STEER THERMOCOOL CATH, EZ STEER THERMOCOOL NAV ... BIOSENSE WEBSTER, INC. P040036 S044 12/17/2015
THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CA... BIOSENSE WEBSTER, INC. P040036 S045 09/12/2014
NAVISTAR THERMOCOOL, NAVISTAR RMT THERMOCOOL, EZ S... BIOSENSE WEBSTER, INC. P040036 S046 11/18/2014
THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CA... BIOSENSE WEBSTER, INC. P040036 S047 11/19/2014
THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATIONAL... BIOSENSE WEBSTER, INC. P040036 S048 03/18/2015
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