BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lymph Node Location System During Sentinel Biopsy Procedure

    PMA: P160053 · Supplement: S004 · Decision Sep 20, 2021
    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
    Magtrace/and Sentimag Magnetic Localization System
    PMA Number
    P160053
    Supplement Number
    S004
    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
    September 20, 2021
    Date Received
    April 1, 2021
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for site located at 305 Ashcake Road, Suite L, Ashland, Virginia 23005 USA

    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