BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Lymph Node Location System During Sentinel Biopsy Procedure

    PMA: P160053 · Supplement: S012 · Decision May 18, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    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
    S012
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    May 18, 2026
    Date Received
    March 17, 2026
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    approval for the generation of a new UDI and reference number for Magtrace products sold specifically in the United States to satisfy traceability and UDI requirements

    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