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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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NAVISTAR (4MM, DS, THERMOCOOL AND RMT) BIOSENSE WEBSTER, INC. P040036 S014 12/14/2009
NAVISTAR ,NAVISTAR RMT ,EZ STEER NAV CATHETERS AN... BIOSENSE WEBSTER, INC. P990025 S039 01/24/2014
NAVISTAR 4 MM BI DIRECTIONAL DIAGNOSTIC/ABLATION C... BIOSENSE WEBSTER, INC. P990025 S013 08/23/2007
NAVISTAR 4 MM BI-DIRECTIONAL DIAGNOSTIC/ABLATION C... BIOSENSE WEBSTER, INC. P990025 S012 10/06/2006
NAVISTAR 4MM, NAVISTAR RMT 4MM, EZ STEER 4MM NAV BIOSENSE WEBSTER, INC. P990025 S042 11/18/2014
NAVISTAR AND CELSIUS THERMOCOOL CATHETERS BIOSENSE WEBSTER, INC. P030031 S020 11/24/2009
NAVISTAR CATHETER, INTERFACE CABLES BIOSENSE WEBSTER, INC. P990025 S025 10/01/2010
NAVISTAR CATHETER, NAVISTAR RMT CATHETER, EZ STEER... BIOSENSE WEBSTER, INC. P990025 S035 07/22/2013
NAVISTAR CATHETER,NAVISTAR RMT CATHETER,EZ STEER N... BIOSENSE WEBSTER, INC. P990025 S036 04/25/2013
NAVISTAR CATHETERS BIOSENSE WEBSTER, INC. P040036 S005 11/14/2007
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