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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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21 to 30 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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Celsius ThermoCool Electrophysiology Catheter, EZ ... BIOSENSE WEBSTER, INC. P030031 S121 07/09/2021
FlexAbility Ablation Catheter (FlexAbility) and Fl... Abbott Medical P110016 S077 06/25/2021
Therapy Cool Path IRVINE BIOMEDICAL, INC. P060019 S053 05/18/2021
FlexAbility and FlexAbility SE Ablation Catheter Abbott Medical P110016 S076 05/18/2021
THERMOCOOL SMARTTOUCH SF Catheter BIOSENSE WEBSTER, INC. P030031 S118 05/13/2021
Safire TX Ablation Catheter, Therapy Dual 8 Ablati... IRVINE BIOMEDICAL,INC.(IBI) P040042 S050 05/04/2021
Therapy Cool Path Ablation Catheter IRVINE BIOMEDICAL, INC. P060019 S052 05/04/2021
Therapy Cool Path Duo Ablation Catheter, Therapy C... Abbott Medical P110016 S075 05/04/2021
Biosense Webster Cables, Celsius DS Catheter, Cels... BIOSENSE WEBSTER, INC. P010068 S063 04/28/2021
Celsius RMT ThermoCool Catheter, Celsius ThermoCoo... BIOSENSE WEBSTER, INC. P030031 S116 04/28/2021
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