BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cancer-Related Germline Gene Mutation Detection System

    PMA: P190014 · Supplement: S004 · Decision Jan 27, 2021
    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
    S004
    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
    January 27, 2021
    Date Received
    July 28, 2020
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for Myriad myChoice® CDx to expand labeling based on SOLO1 study for the treatment of the patients with BRCA mutated advanced ovarian cancer with LYNPARZA (olaparib).

    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