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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 8 of 8 Results
productcode PLS PMA Number p Decision Date From 1/1/2023 Decision Date To 1/1/2024
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VENTANA PD-Ll (SP142) Assay VENTANA MEDICAL SYSTEMS, INC. P160002 S022 11/08/2023
VENTANA PD-Ll (SP263) Assay Ventana Medical Systems, Inc. P160046 S017 11/08/2023
PD-L1 IHC 22C3 pharmDx Agilent Technologies, Inc. P150013 S027 11/07/2023
VENTANA PD-Ll (SP142) Assay VENTANA MEDICAL SYSTEMS, INC. P160002 S021 08/29/2023
VENTANA PD-Ll (SP263) Assay Ventana Medical Systems, Inc. P160046 S016 08/29/2023
PD-L1 IHC 22C3 pharmDx Agilent Technologies, Inc. P150013 S026 07/05/2023
VENTANA PD-L1 (SP263) Assay Ventana Medical Systems, Inc. P160046 S013 03/01/2023
VENTANA PD-L1 (SP142) Assay VENTANA MEDICAL SYSTEMS, INC. P160002 S020 02/07/2023
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