BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Diagnostic Low Electric Field

    PMA: P110014 · Supplement: S009 · Decision Sep 20, 2019
    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
    S009
    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 20, 2019
    Date Received
    August 29, 2019
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    Approval of the revised protocol for the post-approval study (PAS) protocol.

    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