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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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11 to 20 of 50 Results
productcode OAD PMA Number p Decision Date From 1/1/2021 Decision Date To 1/1/2022
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Celsius Fluter, NavistarDS Diagnostic, Celsius DS,... BIOSENSE WEBSTER, INC. P010068 S061 02/02/2021
Celsius RMT ThermoCool Catheter, Celsius ThermoCoo... BIOSENSE WEBSTER, INC. P030031 S124 09/22/2021
Celsius RMT ThermoCool Catheter, Celsius ThermoCoo... BIOSENSE WEBSTER, INC. P030031 S116 04/28/2021
Celsius ThermoCool Electrophysiology Catheter, EZ ... BIOSENSE WEBSTER, INC. P030031 S121 07/09/2021
Celsius Thermocool, EZ Steer Thermocool Non-Nav Bi... BIOSENSE WEBSTER, INC. P030031 S115 04/07/2021
Celsius Thermocool, EZ Steer Thermocool Non-Nav Bi... BIOSENSE WEBSTER, INC. P030031 S114 04/07/2021
CELSIUS THERMOCOOL, THERMOCOOL SF, THERMOCOOL SMAR... BIOSENSE WEBSTER, INC. P030031 S120 09/22/2021
CELSIUS, NAVISTAR and EZ STEER BIOSENSE WEBSTER, INC. P010068 S065 09/22/2021
EZ STEER™DS, EZ STEER™NAV, EZ STEER™, EZ STEER™THE... BIOSENSE WEBSTER, INC. P030031 S117 04/27/2021
FlexAbility Ablation Catheter (FlexAbility) and Fl... Abbott Medical P110016 S077 06/25/2021
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