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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 09/01/2014
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COOLFLOW IRRIGATION PUMP BIOSENSE WEBSTER, INC. P990071 S029 11/19/2014
BIOSENSE WEBSTER CABLES BIOSENSE WEBSTER, INC. P990071 S028 12/17/2015
SMARTABLATE SYSTEM (FORMERLY STOCKERT 70 SYSTEM F... BIOSENSE WEBSTER, INC. P990071 S027 07/02/2014
BIOSENSE WEBSTER CABLES BIOSENSE WEBSTER, INC. P990071 S025 01/24/2014
BIOSENSE WEBSTER CABLES BIOSENSE WEBSTER, INC. P990071 S024 09/05/2013
SMARTABLATE SYSTEM-SMARTABLATE IRRIGATION PUMP KIT BIOSENSE WEBSTER, INC. P990071 S023 07/17/2013
BIOSENSE WEBSTER CABLES BIOSENSE WEBSTER, INC. P990071 S022 04/25/2013
STOCKERT 70 RADIOFREQUENCY GENERATOR FOR CARDIAC A... BIOSENSE WEBSTER, INC. P990071 S020 11/20/2012
STOCKERT RADIOFREQUENCY GENERATOR BIOSENSE WEBSTER, INC. P990071 S019 07/25/2012
THERMOCOOL SF CATHETERS BIOSENSE WEBSTER, INC. P990071 S018 04/12/2013
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