BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lymph Node Location System During Sentinel Biopsy Procedure

    PMA: P160053 · Supplement: S001 · Decision May 8, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Lymph Node Location System During Sentinel Biopsy Procedure
    Trade Name
    MagtraceTM and Sentimag(R) Magnetic Locatization System
    PMA Number
    P160053
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    PUV
    Generic Name
    Lymph node location system during sentinel biopsy procedure
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 8, 2019
    Date Received
    July 30, 2018
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for packaging Magtrace vials with new replacement stoppers (i.e., West 1358).

    Classifications

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

    Product Code Device Name
    PUV Lymph Node Location System During Sentinel Biopsy Procedure