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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 04/18/2015
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NAVISTAR THERMOCOOL AND CELSIUS THERMOCOOL DEFLECT... BIOSENSE WEBSTER, INC. P040036 S002 04/23/2007
NAVISTAR RMT THERMOCOOL LINE EXTENSION BIOSENSE WEBSTER, INC. P040036 S003 01/04/2008
NAVISTAR FAMILY OF CATHETERS BIOSENSE WEBSTER, INC. P040036 S004 10/29/2007
NAVISTAR CATHETERS BIOSENSE WEBSTER, INC. P040036 S005 11/14/2007
EZ STEER THERMOCOOL AND BIOSENSE WEBSTER, INC. P040036 S006 09/30/2008
NAVISTAR THERMOCOOL AND CELSIUS THERMOCOOL DEFLECT... BIOSENSE WEBSTER, INC. P040036 S007 02/05/2009
NAVISTAR RMT THERMOCOOL DIAGNOSTIC / ABLATION STEE... BIOSENSE WEBSTER, INC. P040036 S008 02/20/2009
NAVISTAR RMT THERMOCOOL DIAGNOSTIC/ABLATION STEERA... BIOSENSE WEBSTER, INC. P040036 S009 11/07/2008
NAVISTAR RMT THERMOCOOL BIOSENSE WEBSTER, INC. P040036 S013 11/25/2009
NAVISTAR (4MM, DS, THERMOCOOL AND RMT) BIOSENSE WEBSTER, INC. P040036 S014 12/14/2009
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