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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 11/29/2015
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THERMOCOOK SMARTTOUCH UNI-DIRECTIONAL NAVIGATION C... BIOSENSE WEBSTER, INC. P040036 S051 08/06/2015
SMARTABLATE SYSTEM BIOSENSE WEBSTER, INC. P990071 S031 06/16/2015
CATHETER, PERCUTANEOUS, CARDIAC ABLATION CELSIUS ... BIOSENSE WEBSTER, INC. P030031 S068 06/02/2015
CATHETER, PERCUTANEOUS, CARDIAC ABLATION CELSIUS E... Biosense Webster, Inc P950005 S057 06/02/2015
CATHETER, PERCUTANEOUS, CARDIAC ABLATION NAVISTAR ... BIOSENSE WEBSTER, INC. P990025 S046 06/02/2015
EZ STEER THERMOCOOL NAV, THERMOCOOL SF NAV BIOSENSE WEBSTER, INC. P030031 S067 03/23/2015
EZ STEER THERMOCOOL NAV BIOSENSE WEBSTER, INC. P040036 S050 03/23/2015
EZ STEER NAV BIOSENSE WEBSTER, INC. P990025 S045 03/23/2015
EZ STEER AND THERMOCOOL CATHETER FAMILIES BIOSENSE WEBSTER, INC. P030031 S066 03/19/2015
THERMOCOOL SMART TOUCH BI-DIRECTIONAL CATHETERS BIOSENSE WEBSTER, INC. P040036 S049 03/19/2015
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