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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 30 Results
productcode LPB PMA Number p Decision Date From 1/1/2019 Decision Date To 1/1/2020
 
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Blazer II Cardiac Ablation Catheter and Cable Boston Scientific Corp. P920047 S118 11/07/2019
Chilli II Cooled Ablation Catheter and Cable Boston Scientific Corp. P980003 S091 11/07/2019
Livewire TC Ablation, Livewire TC Cables, Safire A... St. Jude Medical P960016 S080 10/25/2019
Freezor Cardiac Cryoablation System Medtronic CryoCath LP P020045 S090 10/09/2019
Therapy Ablation , Therapy 4mm Thermistor Ablation... IRVINE BIOMEDICAL, INC. P040014 S037 08/28/2019
Maestro 4000 Controller Firmware Boston Scientific Corp. P920047 S117 08/23/2019
Maestro 4000 Controller Firmware Boston Scientific Corp. P980003 S090 08/23/2019
LIVEWIRE(R) CARDIAC ABLATION SYSTEM St. Jude Medical P960016 S079 08/22/2019
EZ Steer Thermocool NAV Catheter and Navistar Ther... BIOSENSE WEBSTER, INC. P040036 S068 08/02/2019
Celsius Catheter Biosense Webster, Inc P950005 S072 08/02/2019
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