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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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productcode PLS PMA Number p Decision Date From 1/1/2019 Decision Date To 1/1/2020
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Ventana PD-Ll (SP142) Assay VENTANA MEDICAL SYSTEMS, INC. P160002 S010 11/19/2019
Ventana PD-Ll (SP263) Assay Ventana Medical Systems, Inc. P160046 S006 11/19/2019
PD-L1 IHC 22C3 pharmDx Agilent Technologies, Inc. P150013 S016 07/30/2019
PD-L1 IHC 22C3 pharmDx Agilent Technologies, Inc. P150013 S014 06/10/2019
PD-L1 IHC 22C3 pharmDx Agilent Technologies, Inc. P150013 S012 04/16/2019
PD-L1 IHC 22C3 PharmDx Agilent Technologies, Inc. P150013 S015 03/13/2019
PD-L1 IHC 28-8 pharmDx Agilent Technologies, Inc. P150025 S011 03/13/2019
VENTANA PD-L1(SP142) Assay. VENTANA MEDICAL SYSTEMS, INC. P160002 S009 03/08/2019
PD-L1 IHC 22C3 pharmDx Agilent Technologies, Inc. P150013 S013 01/17/2019
PD-L1 IHC 28-8 pharmDx Agilent Technologies, Inc. P150025 S010 01/17/2019
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