BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lymph Node Location System During Sentinel Biopsy Procedure

    PMA: P160053 · Supplement: S002 · Decision Dec 6, 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
    S002
    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
    December 6, 2022
    Date Received
    August 30, 2018
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    22M-3128

    Advisory Committee Statement

    Approved to assist in localizing lymph nodes draining a tumor site, as part of a sentinel lymph node biopsy procedure, in patients with breast cancer undergoing a mastectomy or lumpectomy. For patients undergoing lumpectomy, nipple sparing, nipple areolar sparing or skin sparing procedures, Magtrace is indicated to be injected only peritumorally.

    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