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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 01/19/2017
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EZ STEER THERMOCOOL AND BIOSENSE WEBSTER, INC. P040036 S006 09/30/2008
NAVISTAR RMT CATHETER FAMILY BIOSENSE WEBSTER, INC. P030031 S012 11/07/2008
NAVISTAR RMT THERMOCOOL DIAGNOSTIC/ABLATION STEERA... BIOSENSE WEBSTER, INC. P040036 S009 11/07/2008
NAVISTAR RMT DIAGNOSTIC/ABLATION STEERABLE TIP CAT... BIOSENSE WEBSTER, INC. P990025 S016 11/07/2008
NAVISTAR THERMOCOOL & CELSIUS THERMOCOOL DIAGNOSTI... BIOSENSE WEBSTER, INC. P030031 S013 12/24/2008
NAVISTAR THERMOCOOL AND CELSIUS THERMOCOOL DEFLECT... BIOSENSE WEBSTER, INC. P040036 S007 02/05/2009
NAVISTAR RMT THERMOCOOL DIAGNOSTIC / ABLATION STEE... BIOSENSE WEBSTER, INC. P030031 S010 02/20/2009
NAVISTAR RMT THERMOCOOL DIAGNOSTIC / ABLATION STEE... BIOSENSE WEBSTER, INC. P040036 S008 02/20/2009
CELSIUS RMT, NAVISTAR RMT AND NAVISTAR RMT DS CATH... Biosense Webster, Inc P950005 S026 05/13/2009
CELSIUS RMT, NAVISTAR RMT AND NAVISTAR RMT DS CATH... BIOSENSE WEBSTER, INC. P990025 S018 05/13/2009
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