BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Diagnostic Low Electric Field

    PMA: P110014 · Supplement: S012 · Decision Apr 6, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Diagnostic Low Electric Field
    Trade Name
    MarginProbe System
    PMA Number
    P110014
    Supplement Number
    S012
    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
    April 6, 2022
    Date Received
    October 14, 2021
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - PAS
    Expedited Review
    N

    Advisory Committee Statement

    Approval for labeling changes including post-approval study clinical data

    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