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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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Biosense Webster Cables BIOSENSE WEBSTER, INC. P990071 S052 09/22/2021
Freezor, Freezor Xtra and Freezor MAX Cardiac Cryo... Medtronic CryoCath LP P020045 S097 09/10/2021
THERMOCOOL SMARTTOUCH® Uni-Directional Navigation ... BIOSENSE WEBSTER, INC. P040036 S085 09/07/2021
IntellaNav ST Boston Scientific Corp. P920047 S125 09/07/2021
Freezor Xtra Cardiac Cryoablation Catheter Medtronic CryoCath LP P020045 S099 08/22/2021
IntellaNav ST Ablation Catheter, Blazer II Tempera... Boston Scientific Corp. P920047 S124 08/05/2021
EZ Steer ThemoCool Nav Bi-Directional Electrophysi... BIOSENSE WEBSTER, INC. P040036 S083 07/09/2021
Celsius FLTR (Flutter) Catheter, Celsius Electroph... Biosense Webster, Inc P950005 S081 07/09/2021
Smartablate System Interface Cables BIOSENSE WEBSTER, INC. P990071 S050 07/09/2021
7F Freezor Cardiac CryoablationCatheter and CCT.2 ... Medtronic CryoCath LP P020045 S096 06/01/2021
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