BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    PMA: P160038 · Supplement: S002 · Decision Mar 26, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12

    Basic Information

    Device Name
    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
    Trade Name
    Praxis Extended RAS Panel
    PMA Number
    P160038
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    PQP
    Generic Name
    Next generation sequencing oncology panel, somatic or germline variant detection system
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 26, 2018
    Date Received
    March 5, 2018
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the implementation of 100% visual volume inspection of the filled containers.

    Classifications

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

    Product Code Device Name
    PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System