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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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NAVISTAR THERMOCOOL BIOSENSE WEBSTER, INC. P040036 S020 03/12/2010
NAVISTAR THERMOCOOL BIOSENSE WEBSTER, INC. P040036 S021 10/01/2010
7.5 FR NAVI-STAR THERMO-COOL VATHETER WITH THERMIS... BIOSENSE WEBSTER, INC. P040036 S036 05/29/2013
7F CELCIUS THERMO-COOL CATHETER WITH THERMOCOUPLEM... BIOSENSE WEBSTER, INC. P030031 S052 05/29/2013
7F EZ STEER DS BI-DIRECTIONAL NAV CATHETER 4MM TIP... BIOSENSE WEBSTER, INC. P990025 S037 05/29/2013
BI-DIRECTIONAL CELSIUS FLTR CATHETERS (D-1359-XX-S... Biosense Webster, Inc P950005 S041 06/06/2013
BIOSENSE WEBSTER CABLES BIOSENSE WEBSTER, INC. P990071 S022 04/25/2013
BIOSENSE WEBSTER CABLES BIOSENSE WEBSTER, INC. P990071 S025 01/24/2014
BIOSENSE WEBSTER CABLES BIOSENSE WEBSTER, INC. P990071 S024 09/05/2013
BIOSENSE WEBSTER CABLES BIOSENSE WEBSTER, INC. P990071 S034 08/10/2017
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