BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

    PMA: P060017 · Supplement: S003 · Decision Jul 9, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection
    Trade Name
    GENESEARCH BREAST LYMPH NODE ASSAY
    PMA Number
    P060017
    Supplement Number
    S003
    Device Class
    FDA Class 3
    Product Code
    OCB
    Generic Name
    RT-PCR multigene expression test, sentinel lymph node, cancer metastasis detection
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 9, 2009
    Date Received
    March 2, 2009
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR: 1) A MANUFACTURING SITE LOCATED AT VERIDEX, LLC IN WARREN, NEW JERSEY; 2) THE ADDITION OF A SECOND EXISTING SITE; AND 3) A CHANGE IN RAW MATERIAL SPECIFICATIONS.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OCB Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection