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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 07/25/2014
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NAVISTAR CATHETER, INTERFACE CABLES BIOSENSE WEBSTER, INC. P990025 S025 10/01/2010
EZ STEER THERMOCOOL CATHETERS BIOSENSE WEBSTER, INC. P990071 S010 10/01/2010
CELSIUS RMT CATHETER (4MM) Biosense Webster, Inc P950005 S031 02/03/2011
NAVISTAR RMT CATHETER (4MM) BIOSENSE WEBSTER, INC. P990025 S026 02/03/2011
NAVISTAR THERMOCOOL CATHETER FAMILY BIOSENSE WEBSTER, INC. P030031 S023 03/03/2011
NAVISTAR THERMOCOOL CATHETER FAMILY BIOSENSE WEBSTER, INC. P040036 S016 03/03/2011
WEBSTER ELECTROPHYSIOLOGY CATHETER/CELSIUS ABLATIO... Biosense Webster, Inc P950005 S032 03/03/2011
NAVISTAR RMT CATHETER BIOSENSE WEBSTER, INC. P990025 S027 03/03/2011
CELSIUS THERMOCOOL/RMT//NAVISTAR/NAVISTAR RMT/EZ S... BIOSENSE WEBSTER, INC. P030031 S032 04/06/2011
NAVISTAR THERMOCOOL//NAVISTAR RMT//EZ STEER/EZ STE... BIOSENSE WEBSTER, INC. P040036 S023 04/06/2011
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