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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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Device
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PMA
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MetriQ Pump Boston Scientific Corp. P150005 S062 03/03/2021
Navistar DS, Celsius DS, EZ Steer DS Bi-directiona... BIOSENSE WEBSTER, INC. P010068 S062 04/07/2021
NaviStar THERMOCOOL Deflectable Diagnostic/Ablatio... BIOSENSE WEBSTER, INC. P030031 S102 01/28/2021
RMT THERMOCOOL, NAVISTAR™, NAVISTAR™RMT, NAVISTAR™... BIOSENSE WEBSTER, INC. P010068 S064 04/27/2021
Safire TX Ablation Catheter, Therapy Dual 8 Ablati... IRVINE BIOMEDICAL,INC.(IBI) P040042 S050 05/04/2021
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 IRVINE BIOMEDICAL, INC. P060019 S053 05/18/2021
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
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