BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cancer-Related Germline Gene Mutation Detection System

    PMA: P190014 · Supplement: S010 · Decision Oct 4, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Cancer-Related Germline Gene Mutation Detection System
    Trade Name
    MyChoice® CDx
    PMA Number
    P190014
    Supplement Number
    S010
    Device Class
    FDA Class 3
    Product Code
    PJG
    Generic Name
    Cancer-related germline gene mutation detection system
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 4, 2024
    Date Received
    June 14, 2024
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval of manufacturing site change for MyChoice® CDx

    Classifications

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

    Product Code Device Name
    PJG Cancer-Related Germline Gene Mutation Detection System