BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Diagnostic Low Electric Field

    PMA: P110014 · Supplement: S008 · Decision Jun 19, 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
    S008
    Device Class
    FDA Class 3
    Product Code
    OEE
    Generic Name
    Diagnostic low electric field
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    June 19, 2019
    Date Received
    May 21, 2019
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    New sterilization chamber (No. 8) that has been installed and validated at the Company’s approved contract sterilizer, Mediplast Isreal, Ltd. (Tel Aviv Israel, FDA Registration Number 3008729892).

    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