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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 22 Results
productcode LPB PMA Number p Decision Date From 1/1/2023 Decision Date To 1/1/2024
 
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7F Freezor Cardiac Cryoablation Catheter, 7F Freez... Medtronic CryoCath LP P020045 S102 01/19/2023
SmartAblate™ Irrigation Tubing Set BIOSENSE WEBSTER, INC. P990071 S055 01/24/2023
Thermocool Smarttouch Bi-directional Catheter, The... BIOSENSE WEBSTER, INC. P040036 S093 03/10/2023
Blazer II Cardiac Ablation System Boston Scientific Corp. P920047 S130 04/27/2023
Chilli II Cooled RF Ablation System Boston Scientific Corp. P980003 S095 04/27/2023
CryoConsole Medtronic CryoCath LP P020045 S103 05/02/2023
Thermocool Smarttouch BIOSENSE WEBSTER, INC. P040036 S094 05/03/2023
CryoConsole Medtronic CryoCath LP P020045 S104 05/31/2023
EZ Steer ThermoCool Nav Catheter, EZ Steer ThermoC... BIOSENSE WEBSTER, INC. P040036 S095 06/12/2023
Deflectable Diagnostic/Ablation Catheter, EZ Steer... Biosense Webster, Inc P950005 S086 06/12/2023
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