BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

    PMA: P830063 · Decision May 27, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma
    Trade Name
    GAMBRO FIBER PLASMAFILTER
    PMA Number
    P830063
    Device Class
    FDA Class 3
    Product Code
    MDP
    Generic Name
    Separator for therapeutic purposes, membrane automated blood cell/plasma
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 27, 1986
    Date Received
    October 4, 1983
    Expedited Review
    N
    Docket Number
    86M-0250

    Advisory Committee Statement

    Approval for the Gambro Fiber Plasmafilter PP. This device is indicated for use in performing therapeutic plasma separation from whole blood in a clinical setting to remove circulation plasma components or protein bound toxins.

    Classifications

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

    Product Code Device Name
    MDP Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma