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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 50 Results
productcode OAD PMA Number p Decision Date From 1/1/2021 Decision Date To 1/1/2022
 
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Device
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PMA
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Celsius Fluter, NavistarDS Diagnostic, Celsius DS,... BIOSENSE WEBSTER, INC. P010068 S061 02/02/2021
Navistar DS, Celsius DS, EZ Steer DS Bi-directiona... BIOSENSE WEBSTER, INC. P010068 S062 04/07/2021
Biosense Webster Cables, Celsius DS Catheter, Cels... BIOSENSE WEBSTER, INC. P010068 S063 04/28/2021
RMT THERMOCOOL, NAVISTAR™, NAVISTAR™RMT, NAVISTAR™... BIOSENSE WEBSTER, INC. P010068 S064 04/27/2021
CELSIUS, NAVISTAR and EZ STEER BIOSENSE WEBSTER, INC. P010068 S065 09/22/2021
Celsius FLTR (Flutter) Catheter, EZ STEER NAV Bi-D... BIOSENSE WEBSTER, INC. P010068 S066 07/09/2021
Biosense Webster Cables, Celsius DS Catheter, Cels... BIOSENSE WEBSTER, INC. P010068 S068 09/22/2021
Blazer II XP Temperature Ablation Catheter, Blazer... BOSTON SCIENTIFIC P020025 S129 08/05/2021
IntellaTip MiFi Filter Module and IntellaTip MiFi ... BOSTON SCIENTIFIC P020025 S130 04/08/2021
IntellaTip MiFi Filter Module, IntellaTip MiFi Ref... BOSTON SCIENTIFIC P020025 S132 08/17/2021
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