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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 10/22/2014
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Smartablate System Interface Cables BIOSENSE WEBSTER, INC. P990071 S050 07/09/2021
SmartAblate System Foot Pedal. BIOSENSE WEBSTER, INC. P990071 S036 08/23/2017
SMARTABLATE SYSTEM (FORMERLY STOCKERT 70 SYSTEM F... BIOSENSE WEBSTER, INC. P990071 S027 07/02/2014
SMARTABLATE SYSTEM BIOSENSE WEBSTER, INC. P990071 S031 06/16/2015
SMARTABLATE SYSTEM BIOSENSE WEBSTER, INC. P990071 S030 12/12/2014
SmartAblate System BIOSENSE WEBSTER, INC. P990071 S039 06/15/2018
SmartAblate Irrigation Tubing Set and nGEN Pump BIOSENSE WEBSTER, INC. P990071 S054 06/08/2022
SmartAblate Irrigation Tubing Set BIOSENSE WEBSTER, INC. P990071 S053 03/15/2022
SmartAblate Irrigation Tubing Set BIOSENSE WEBSTER, INC. P990071 S059 02/19/2024
SmartAblate Irrigation Tubing Set BIOSENSE WEBSTER, INC. P990071 S047 12/23/2021
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