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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Applicant BIOSENSE WEBSTER, INC. productcode OAE Decision Date To 04/30/2024
 
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NAVISTAR & CELSIUS THERMOCOOL CATHETERS BIOSENSE WEBSTER, INC. P030031 S011 02/06/2009
THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER (D-1313-... BIOSENSE WEBSTER, INC. P030031 S025 12/21/2011
THERMOCOOL SF NAV UNI-DIRECTIONAL CATHETER (D-1315... BIOSENSE WEBSTER, INC. P030031 S034 12/21/2011
THERMACOOL SF BI-DIRECTIONAL AND UNI-DIRECTIONAL C... BIOSENSE WEBSTER, INC. P030031 S038 03/23/2012
UNIDIRECTIONAL THERMOCOOL SF NAV CATHETER BIOSENSE WEBSTER, INC. P030031 S045 10/02/2012
THERMOCOOL SMARTTOUCH SF UNI-DIRECTIONAL NAVIGATIO... BIOSENSE WEBSTER, INC. P030031 S072 08/11/2016
THERMOCOOL SMARTTOUCH® Catheter BIOSENSE WEBSTER, INC. P030031 S126 07/18/2023
QDOT MICRO™ System Biosense Webster, Inc. P210027 11/23/2022
QDOT MICRO™ System, nGEN™ Generator Biosense Webster, Inc. P210027 S001 02/24/2023
QDOT MICRO CATHETER, nGEN RF Generator, TX eco Cab... Biosense Webster, Inc. P210027 S002 07/20/2023
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