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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 10/22/2014
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NAVISTAR/RMT/EZ STEER NAV/QWIKSTAR/INTERFACE CABLE... BIOSENSE WEBSTER, INC. P990025 S028 04/06/2011
NAVISTAR/NAVISTAR RMT/EZ STEER NAV/QWIKSTAR CATHET... BIOSENSE WEBSTER, INC. P990025 S029 10/07/2011
NAVISTAR/NAVISTAR RMT/EZ STEER NAV/QWIKSTAR BIOSENSE WEBSTER, INC. P990025 S023 03/04/2010
NAVISTAR/NAVISTAR RMT THERMOCOOL/EZ STEER THERMOCO... BIOSENSE WEBSTER, INC. P040036 S026 10/07/2011
NAVISTAR/EZ STEER NAV/QWIKSTAR BIOSENSE WEBSTER, INC. P990025 S024 03/12/2010
NAVISTAR, NAVISTAR RMT, EZ STEER NAV CATHETERS BIOSENSE WEBSTER, INC. P990025 S032 04/12/2013
NAVISTAR THERMOCOOL/NAVISTAR RMT THERMOCOOL/ EZ ST... BIOSENSE WEBSTER, INC. P030031 S026 03/04/2010
NAVISTAR THERMOCOOL/NAVISTAR RMT THERMOCOOL/ EZ ST... BIOSENSE WEBSTER, INC. P040036 S019 03/04/2010
NAVISTAR THERMOCOOL//NAVISTAR RMT//EZ STEER/EZ STE... BIOSENSE WEBSTER, INC. P040036 S023 04/06/2011
NAVISTAR THERMOCOOL, THERMOCOOL SMARTTOUCH (ST) BIOSENSE WEBSTER, INC. P040036 S089 09/09/2022
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