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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 Decision Date To 11/29/2015
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CELSIUS FLTR UNI-DIRECTIONAL CATHETER Biosense Webster, Inc P950005 S052 09/12/2014
NAVISTAR THERMOCOOL BIOSENSE WEBSTER, INC. P040036 S043 08/01/2014
CELSIUS CATHETER, CELSIUS RMT CATHETER Biosense Webster, Inc P950005 S050 07/02/2014
SMARTABLATE SYSTEM (FORMERLY STOCKERT 70 SYSTEM F... BIOSENSE WEBSTER, INC. P990071 S027 07/02/2014
NAVISTAR RMT THERMOCOOL, D-1266-XX, CELSIUS RMT TH... BIOSENSE WEBSTER, INC. P030031 S044 07/01/2014
NAVISTAR RMT THERMOCOOL CATHETER BIOSENSE WEBSTER, INC. P040036 S032 07/01/2014
THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CA... BIOSENSE WEBSTER, INC. P030031 S053 02/11/2014
THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CA... BIOSENSE WEBSTER, INC. P040036 S037 02/11/2014
CELCIUS/ RMT THERMOCOOL ,NAVISTAR THERMOCOOL ,NAVI... BIOSENSE WEBSTER, INC. P030031 S058 01/24/2014
NAVISTAR THERMOCOOL CATHETER,NAVISTAR RMT THERMOCO... BIOSENSE WEBSTER, INC. P040036 S041 01/24/2014
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