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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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31 to 40 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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RMT THERMOCOOL, NAVISTAR™, NAVISTAR™RMT, NAVISTAR™... BIOSENSE WEBSTER, INC. P010068 S064 04/27/2021
EZ STEER™DS, EZ STEER™NAV, EZ STEER™, EZ STEER™THE... BIOSENSE WEBSTER, INC. P030031 S117 04/27/2021
IntellaTip MiFi Filter Module and IntellaTip MiFi ... BOSTON SCIENTIFIC P020025 S130 04/08/2021
Navistar DS, Celsius DS, EZ Steer DS Bi-directiona... BIOSENSE WEBSTER, INC. P010068 S062 04/07/2021
Celsius Thermocool, EZ Steer Thermocool Non-Nav Bi... BIOSENSE WEBSTER, INC. P030031 S114 04/07/2021
Celsius Thermocool, EZ Steer Thermocool Non-Nav Bi... BIOSENSE WEBSTER, INC. P030031 S115 04/07/2021
THERMOCOOL SMARTTOUCH SF Catheter BIOSENSE WEBSTER, INC. P030031 S109 03/26/2021
Therapy and Therapy Dual-8 and Safire TX Ablation ... IRVINE BIOMEDICAL,INC.(IBI) P040042 S049 03/24/2021
Therapy Cool Path IRVINE BIOMEDICAL, INC. P060019 S051 03/24/2021
Therapy Cool Path Duo and Therapy Cool Flex Abbott Medical P110016 S074 03/24/2021
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