BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lymph Node Location System During Sentinel Biopsy Procedure

    PMA: P160053 · Supplement: S005 · Decision Sep 13, 2022
    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
    S005
    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 13, 2022
    Date Received
    March 24, 2022
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approved for using new Gen 3 and Gen 3T Sentimag detectors to detect Magtrace, addition of CIDEX OPA as a high level disinfectant for disinfecting Sentimag Gen 3 and Gen 3T detectors, and addition of certain low temperature sterilization systems for certain cycles for sterilization of Sentimag Gen 3 and Gen 3T detectors.

    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