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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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productcode OAD PMA Number p Decision Date From 1/1/2021 Decision Date To 1/1/2022
 
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PMA
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Ampere™ Generator Abbott Medical P110016 S079 10/14/2021
Ampere™ Generator IRVINE BIOMEDICAL, INC. P060019 S054 10/14/2021
Ampere™ Generator IRVINE BIOMEDICAL,INC.(IBI) P040042 S051 10/14/2021
Biosense Webster Cables, Celsius DS Catheter, Cels... BIOSENSE WEBSTER, INC. P010068 S068 09/22/2021
Biosense Webster Cables, Celsius DS Catheter, Cels... BIOSENSE WEBSTER, INC. P010068 S063 04/28/2021
Blazer II XP Temperature Ablation Catheter, Blazer... BOSTON SCIENTIFIC P020025 S129 08/05/2021
Blazer Open Irrigated Ablation Catheter Boston Scientific Corp. P150005 S066 08/06/2021
Blazer Open-Irrigated Ablation Catheter Boston Scientific Corp. P150005 S063 07/14/2021
Blazer Open-Irrigated Ablation Catheter, IntellaNa... Boston Scientific Corp. P150005 S061 08/05/2021
Celsius FLTR (Flutter) Catheter, EZ STEER NAV Bi-D... BIOSENSE WEBSTER, INC. P010068 S066 07/09/2021
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