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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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productcode OAD PMA Number p Decision Date From 1/1/2021 Decision Date To 1/1/2022
 
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FlexAbility Ablation Catheter, Sensor Enabled Abbott Medical P110016 S072 01/06/2021
Therapy Cool Path Duo, Safire BLU Duo, Cool Path, ... Abbott Medical P110016 S073 03/12/2021
Therapy Cool Path Duo and Therapy Cool Flex Abbott Medical P110016 S074 03/24/2021
Therapy Cool Path Duo Ablation Catheter, Therapy C... Abbott Medical P110016 S075 05/04/2021
FlexAbility and FlexAbility SE Ablation Catheter Abbott Medical P110016 S076 05/18/2021
FlexAbility Ablation Catheter (FlexAbility) and Fl... Abbott Medical P110016 S077 06/25/2021
FlexAbility Ablation Catheter, FlexAbility Ablatio... Abbott Medical P110016 S078 09/22/2021
Ampere™ Generator Abbott Medical P110016 S079 10/14/2021
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
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