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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 10/22/2016
 
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NAVISTAR THERMOCOOL AND CELSIUS THERMOCOOL DEFLECT... BIOSENSE WEBSTER, INC. P030031 S004 04/23/2007
NAVISTAR RMT THERMOCOOL DIAGNOSTIC/ABLATION DEFLEC... BIOSENSE WEBSTER, INC. P030031 S005 01/04/2008
NAVISTAR THERMOCOOL CATHETER FOR TREATMENT OF TYPE... BIOSENSE WEBSTER, INC. P030031 S006 11/28/2007
NAVISTAR & CELSIUS FAMILIES OF CATHETERS BIOSENSE WEBSTER, INC. P030031 S007 10/29/2007
NAVISTAR & CELSIUS CATHETERS BIOSENSE WEBSTER, INC. P030031 S008 11/14/2007
EZ STEER THERMOCOOL AND EZ STEER THERMOCOOL NAV DI... BIOSENSE WEBSTER, INC. P030031 S009 09/30/2008
NAVISTAR RMT THERMOCOOL DIAGNOSTIC / ABLATION STEE... BIOSENSE WEBSTER, INC. P030031 S010 02/20/2009
NAVISTAR RMT CATHETER FAMILY BIOSENSE WEBSTER, INC. P030031 S012 11/07/2008
NAVISTAR THERMOCOOL & CELSIUS THERMOCOOL DIAGNOSTI... BIOSENSE WEBSTER, INC. P030031 S013 12/24/2008
NAVISTAR THERMOCOOL CATHETER BIOSENSE WEBSTER, INC. P030031 S014 08/12/2009
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