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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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41 to 50 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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Therapy Cool Path, Safire BLU, Safire BLU SP, and ... IRVINE BIOMEDICAL,INC.(IBI) P040042 S048 03/12/2021
Therapy Cool Path, Safire BLU, Safire BLU SP, and ... IRVINE BIOMEDICAL, INC. P060019 S050 03/12/2021
Therapy Cool Path Duo, Safire BLU Duo, Cool Path, ... Abbott Medical P110016 S073 03/12/2021
MetriQ Pump Boston Scientific Corp. P150005 S062 03/03/2021
Thermocool Smarttouch SF BIOSENSE WEBSTER, INC. P030031 S113 03/02/2021
Celsius Fluter, NavistarDS Diagnostic, Celsius DS,... BIOSENSE WEBSTER, INC. P010068 S061 02/02/2021
Thermocool SF NAV, Celsius Thermocool, EZ Steer Th... BIOSENSE WEBSTER, INC. P030031 S112 02/02/2021
NaviStar THERMOCOOL Deflectable Diagnostic/Ablatio... BIOSENSE WEBSTER, INC. P030031 S102 01/28/2021
ThermoCool SmartTouch Catheters BIOSENSE WEBSTER, INC. P030031 S111 01/22/2021
FlexAbility Ablation Catheter, Sensor Enabled Abbott Medical P110016 S072 01/06/2021
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