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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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21 to 30 of 33 Results
productcode LPB PMA Number p Decision Date From 1/1/2020 Decision Date To 1/1/2021
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Device
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PMA
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IntellaNav ST Boston Scientific Corp. P920047 S119 01/27/2020
Freezor, Arctic Front Advance (AFA) CryoAblation C... Medtronic CryoCath LP P020045 S093 02/03/2020
Freezor Cardiac Cryoablation Catheter Medtronic CryoCath LP P020045 S092 03/02/2020
EZ Steer ThermoCool Catheter, EZ Steer ThermoCool ... BIOSENSE WEBSTER, INC. P040036 S072 04/16/2020
EZ Steer DS Bi-Directional Electrophysiology Cathe... Biosense Webster, Inc P950005 S075 09/24/2020
Chilli II Cooled Ablation Catheter and Cable Boston Scientific Corp. P980003 S092 05/19/2020
Celsius Electrophysiology Catheter, Deflectable Ti... Biosense Webster, Inc P950005 S073 02/26/2020
Celsius Catheter, Celsius RMT Catheter, Celsius FL... Biosense Webster, Inc P950005 S074 04/16/2020
Catheter RF Contactr, Catheter RF Enhancr II, RF C... MEDTRONIC Inc. P930029 S068 12/15/2020
Blazer Prime XP cardiac ablation catheters Boston Scientific Corp. P920047 S123 06/04/2020
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