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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 7 of 7 Results
productcode DRF PMA Number p Decision Date From 1/1/2021 Decision Date To 1/1/2022
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PMA
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CELSIUS and EZ STEER BIOSENSE WEBSTER, INC. P990025 S065 09/22/2021
Biosense Webster Cables, EZ Steer Nav Catheter, Na... BIOSENSE WEBSTER, INC. P990025 S068 09/22/2021
Interface CABLES, Navistar Electrophysiology Cathe... BIOSENSE WEBSTER, INC. P990025 S066 07/09/2021
Biosense Webster Cables, EZ Steer Nav Catheter, Na... BIOSENSE WEBSTER, INC. P990025 S063 04/28/2021
NAVISTAR™RMT THERMOCOOL, NAVISTAR™DS, EZ STEER™NAV... BIOSENSE WEBSTER, INC. P990025 S064 04/27/2021
Navistar, Navistar RMT, EZ Steer Nav Bi-directiona... BIOSENSE WEBSTER, INC. P990025 S062 04/07/2021
Navistar EP, EZ Steer Nav Bi-Directional BIOSENSE WEBSTER, INC. P990025 S061 02/02/2021
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