BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P060017 · Supplement: S001 · Decision Oct 23, 2007
    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
    PMA Number
    P060017
    Supplement Number
    S001
    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
    October 23, 2007
    Date Received
    August 15, 2007
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol - OSB
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE POST-APPROVAL STUDY.

    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