BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Diagnostic Low Electric Field

    PMA: P110014 · Supplement: S013 · Decision Sep 17, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Diagnostic Low Electric Field
    Trade Name
    MarginProbe
    PMA Number
    P110014
    Supplement Number
    S013
    Device Class
    FDA Class 3
    Product Code
    OEE
    Generic Name
    Diagnostic low electric field
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 17, 2025
    Date Received
    January 22, 2025
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the modification of the MP 2.0 System including MP 2.0 Console and MP 2.a Probe with the use of multiple array technology with multiple sensors.

    Classifications

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

    Product Code Device Name
    OEE Diagnostic Low Electric Field