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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 05/03/2016
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EZ Steer ThermoCool Catheter, EZ Steer ThermoCool ... BIOSENSE WEBSTER, INC. P040036 S072 04/16/2020
EZ Steer ThermoCool Catheter, EZ Steer ThermoCool ... BIOSENSE WEBSTER, INC. P040036 S080 04/28/2021
EZ STEER THERMOCOOL CATHETERS BIOSENSE WEBSTER, INC. P990071 S010 10/01/2010
EZ STEER THERMOCOOL NAV BIOSENSE WEBSTER, INC. P040036 S050 03/23/2015
EZ STEER THERMOCOOL NAV BIOSENSE WEBSTER, INC. P040036 S038 08/22/2013
EZ STEER THERMOCOOL NAV CATHETER BIOSENSE WEBSTER, INC. P030031 S022 07/07/2010
EZ STEER THERMOCOOL NAV CATHETER BIOSENSE WEBSTER, INC. P040036 S015 07/07/2010
EZ Steer Thermocool NAV Catheter and Navistar Ther... BIOSENSE WEBSTER, INC. P040036 S068 08/02/2019
EZ Steer ThermoCool Nav Catheter, EZ Steer ThermoC... BIOSENSE WEBSTER, INC. P040036 S095 06/12/2023
EZ STEER THERMOCOOL NAV, THERMOCOOL SF NAV BIOSENSE WEBSTER, INC. P030031 S067 03/23/2015
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