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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 1/1/2018 Decision Date To 1/1/2019
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VENTANA PD-L1(SP142) Assay VENTANA MEDICAL SYSTEMS, INC. P160002 S007 09/13/2018
VENTANA PD-L1 (SP263) Assay Ventana Medical Systems, Inc. P160046 S005 09/13/2018
PD-L1 IHC 22C3 pharmDx Agilent Technologies, Inc. P150013 S011 08/16/2018
VENTANA PD-L1(SP142) CDX ASSAY VENTANA MEDICAL SYSTEMS, INC. P160002 S006 07/02/2018
PD-L1 IHC 22C3 pharmDx Agilent Technologies, Inc. P150013 S009 06/12/2018
Ventana PD-L1 (SP263) Ventana Medical Systems, Inc. P160046 S004 06/01/2018
PD-L1 IHC 22C3 PharmDx Agilent Technologies, Inc. P150013 S010 04/10/2018
PD-L1 IHC 28-8 pharmDx Agilent Technologies, Inc. P150025 S009 04/10/2018
PD L1 IHC 22C3 pharmDx Agilent Technologies, Inc. P150013 S008 01/22/2018
PD-L1 IHC 28-8 pharmDx Agilent Technologies, Inc. P150025 S008 01/22/2018
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