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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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PMA
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CELSIUS RMT, NAVISTAR RMT AND NAVISTAR RMT DS CATH... Biosense Webster, Inc P950005 S026 05/13/2009
CELSIUS RMT, NAVISTAR RMT AND NAVISTAR RMT DS CATH... BIOSENSE WEBSTER, INC. P990025 S018 05/13/2009
CELSIUS THERMOCOOL & NAVISTAR THERMOCOOL BIOSENSE WEBSTER, INC. P030031 S027 03/12/2010
CELSIUS THERMOCOOL & NAVISTAR THERMOCOOL BIOSENSE WEBSTER, INC. P030031 S028 10/01/2010
CELSIUS THERMOCOOL CATHETER BIOSENSE WEBSTER, INC. P030031 S030 07/15/2010
CELSIUS THERMOCOOL CATHETER BIOSENSE WEBSTER, INC. P030031 S043 07/23/2012
CELSIUS THERMOCOOL CATHETER, CELSIUS RMT THERMOCOO... BIOSENSE WEBSTER, INC. P030031 S050 07/22/2013
CELSIUS THERMOCOOL CATHETERS BIOSENSE WEBSTER, INC. P030031 S048 10/24/2012
CELSIUS THERMOCOOL, CELSIUS RMT THERMOCOOL, NAVIST... BIOSENSE WEBSTER, INC. P030031 S042 04/12/2013
CELSIUS THERMOCOOL, THERMOCOOL SF, NAVISTAR THERMO... BIOSENSE WEBSTER, INC. P030031 S071 11/05/2015
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