BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

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

    PMA: P060017 · Supplement: S004 · Decision Dec 17, 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 (BLN) ASSAY
    PMA Number
    P060017
    Supplement Number
    S004
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 17, 2009
    Date Received
    November 19, 2009
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    EXTENSION OF SHELF-LIFE OF PLASMID DNA RAW MATERIAL USED IN THE MANUFACTURE OF THE EXTERNAL POSITIVE AND EXTERNAL NEGATIVE CONTROLS OF THE DEVICE.

    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