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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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11 to 20 of 39 Results
productcode LPB PMA Number p Decision Date From 1/1/2021 Decision Date To 1/1/2022
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PMA
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Celsius, Celsius Flutter, EZ Steer Biosense Webster, Inc P950005 S076 02/02/2021
Celsius, Celsius RMT, EZ Steer Bi-directional non ... Biosense Webster, Inc P950005 S077 04/07/2021
CELSIUS™, CELSIUS™DS, CELSIUS™RMT, CELSIUS™THERMOC... Biosense Webster, Inc P950005 S079 04/27/2021
EZ Steer ThemoCool Nav Bi-Directional Electrophysi... BIOSENSE WEBSTER, INC. P040036 S083 07/09/2021
EZ Steer ThermoCool Nav Deflectable Diagnostic/Ab... BIOSENSE WEBSTER, INC. P040036 S070 01/28/2021
EZ Steer ThermoCool Catheter, EZ Steer ThermoCool ... BIOSENSE WEBSTER, INC. P040036 S086 09/22/2021
EZ Steer ThermoCool Catheter, EZ Steer ThermoCool ... BIOSENSE WEBSTER, INC. P040036 S080 04/28/2021
EZ Steer Thermocool, EZ Steer Thermocool Bi-Direct... BIOSENSE WEBSTER, INC. P040036 S077 02/02/2021
EZ STEER™THERMOCOOL, THERMOCOOL™SF NAV, THERMOCOOL... BIOSENSE WEBSTER, INC. P040036 S081 04/27/2021
Freezor Cardiac Cryoablation System Medtronic CryoCath LP P020045 S095 10/12/2021
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