BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cancer-Related Germline Gene Mutation Detection System

    PMA: P140020 · Supplement: S015 · Decision Oct 16, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Cancer-Related Germline Gene Mutation Detection System
    Trade Name
    BRACAnalysis CDx device
    PMA Number
    P140020
    Supplement Number
    S015
    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 16, 2018
    Date Received
    April 9, 2018
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for extending the label claim of the BRACAnalysis CDx to include an indication for TALZENNA (talazoparib) in breast cancer patients.

    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