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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 1/1/2016 Decision Date To 1/1/2017
 
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VENTANA PD-L1(SP142) CDX ASSAY VENTANA MEDICAL SYSTEMS, INC. P160002 S001 12/21/2016
PD-L1 IHC 22C3 PHARMDX Agilent Technologies, Inc. P150013 S003 12/01/2016
PD-L1 IHC 28-8 PHARMDX (Non-Squamous Indication) Agilent Technologies, Inc. P150025 S002 12/01/2016
PD-L1 IHC 28-8 PHARMDX (Melanoma Indication) DAKO NORTH AMERICA, INC. P150027 S002 12/01/2016
PD-L1 IHC 22C3 PHARMDX Agilent Technologies, Inc. P150013 S001 10/24/2016
VENTANA PD-L1 (SP142) Assay VENTANA MEDICAL SYSTEMS, INC. P160006 10/18/2016
PD-L1 IHC 28-8 PHARMDX (NON-SQUAMOUS NSCLC INDICAT... Agilent Technologies, Inc. P150025 S001 10/05/2016
PD-L1 IHC 28-8 PHARMDX (MELANOMA INDICATION) DAKO NORTH AMERICA, INC. P150027 S001 10/05/2016
PD-L1 IHC 22C3 PHARMDX Agilent Technologies, Inc. P150013 S002 09/23/2016
VENTANA PD-L1(SP142) CDX ASSAY VENTANA MEDICAL SYSTEMS, INC. P160002 05/18/2016
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