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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 08/26/2016
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EZ Steer Thermocool, EZ Steer Thermocool Bi-Direct... BIOSENSE WEBSTER, INC. P040036 S077 02/02/2021
EZ STEER™THERMOCOOL, THERMOCOOL™SF NAV, THERMOCOOL... BIOSENSE WEBSTER, INC. P040036 S081 04/27/2021
Interface Cables BIOSENSE WEBSTER, INC. P990071 S057 06/12/2023
INTERFACE CABLES BIOSENSE WEBSTER, INC. P990071 S015 10/07/2011
INTERFACE CABLES BIOSENSE WEBSTER, INC. P990071 S012 04/06/2011
NAVI-STAR CATHETERS BIOSENSE WEBSTER, INC. P990025 S034 10/24/2012
NAVI-STAR RMT ELECTROPHYSIOLOGY CATHETER BIOSENSE WEBSTER, INC. P990025 S041 10/21/2014
NAVISTAR BIOSENSE WEBSTER, INC. P990025 S047 11/05/2015
NAVISTAR & CELSIUS CATHETERS BIOSENSE WEBSTER, INC. P030031 S008 11/14/2007
NAVISTAR & CELSIUS FAMILIES OF CATHETERS BIOSENSE WEBSTER, INC. P030031 S007 10/29/2007
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