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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 12/02/2016
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NAVISTAR THERMOCOOL CATHETER BIOSENSE WEBSTER, INC. P030031 S014 08/12/2009
NAVISTAR THERMOCOOL AND NAVISTAR RMT THERMOCOOL CA... BIOSENSE WEBSTER, INC. P990025 S022 12/14/2009
NAVISTAR THERMOCOOL AND CELSIUS THERMOCOOL DEFLECT... BIOSENSE WEBSTER, INC. P030031 S004 04/23/2007
NAVISTAR THERMOCOOL AND CELSIUS THERMOCOOL DEFLECT... BIOSENSE WEBSTER, INC. P040036 S002 04/23/2007
NAVISTAR THERMOCOOL AND CELSIUS THERMOCOOL DEFLECT... BIOSENSE WEBSTER, INC. P040036 S007 02/05/2009
NAVISTAR THERMOCOOL & CELSIUS THERMOCOOL DIAGNOSTI... BIOSENSE WEBSTER, INC. P030031 S013 12/24/2008
NAVISTAR THERMOCOOL BIOSENSE WEBSTER, INC. P030031 S054 08/22/2013
NAVISTAR THERMOCOOL BIOSENSE WEBSTER, INC. P040036 S043 08/01/2014
Navistar Thermo Cool Deflectable Diagnostic/Ablati... BIOSENSE WEBSTER, INC. P040036 S061 10/17/2017
NAVISTAR RMT THERMOCOOL, D-1266-XX, CELSIUS RMT TH... BIOSENSE WEBSTER, INC. P030031 S044 07/01/2014
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