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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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11 to 20 of 50 Results
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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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
NaviStar THERMOCOOL Deflectable Diagnostic/Ablatio... BIOSENSE WEBSTER, INC. P030031 S102 01/28/2021
THERMOCOOL SMARTTOUCH SF Catheter BIOSENSE WEBSTER, INC. P030031 S109 03/26/2021
VISITAG SURPOINT External Processing Unit (EPU) BIOSENSE WEBSTER, INC. P030031 S110 11/12/2021
ThermoCool SmartTouch Catheters BIOSENSE WEBSTER, INC. P030031 S111 01/22/2021
Thermocool SF NAV, Celsius Thermocool, EZ Steer Th... BIOSENSE WEBSTER, INC. P030031 S112 02/02/2021
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