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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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THERMOCOOL SF BI-DIRECTIONAL AND UNI-DIRECTIONAL C... BIOSENSE WEBSTER, INC. P030031 S039 06/15/2012
THERMOCOOL SF BIOSENSE WEBSTER, INC. P040036 S040 10/09/2013
THERMOCOOK SMARTTOUCH UNI-DIRECTIONAL NAVIGATION C... BIOSENSE WEBSTER, INC. P040036 S051 08/06/2015
THERMO-COOL SF (BI-DIRECTIONAL AND UNI-DIRECTIONAL... BIOSENSE WEBSTER, INC. P030031 S061 10/15/2014
Therapeutic Catheters Biosense Webster, Inc P950005 S065 07/27/2017
Stockert SMARTABLATE System BIOSENSE WEBSTER, INC. P990071 S046 09/23/2021
STOCKERT RADIOFREQUENCY GENERATOR BIOSENSE WEBSTER, INC. P990071 S019 07/25/2012
Stockert 70 RF Generator Foot Pedal BIOSENSE WEBSTER, INC. P990071 S035 06/21/2017
STOCKERT 70 RADIOFREQUENCY GENERATOR FOR CARDIAC A... BIOSENSE WEBSTER, INC. P990071 S008 04/19/2006
STOCKERT 70 RADIOFREQUENCY GENERATOR FOR CARDIAC A... BIOSENSE WEBSTER, INC. P990071 S007 07/12/2005
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