BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

    PMA: P830063 · Supplement: S001 · Decision Aug 28, 1996
    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 AB PLASMAFILTER PF 2000N AND EXCORIM KB MAXO PLASMAFILTER
    PMA Number
    P830063
    Supplement Number
    S001
    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
    August 28, 1996
    Date Received
    July 6, 1995
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE OF MATERIAL USED IN THE HOUSING OF THE DEVICE, END CAP CONFIGURAITON MODIFICATION AND SPECIFICATION CHAGNES TO THE DEVICE MEMBRANE (I.E., DECREASE IN NUMBER OF HOLLOW FIBERS AND INCREASE IN HOLLOW FIBER LENGTH). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GAMBRO AB PLASMAFILTER PF 2000N AND EXCORIM KB MAXO PLASMAFILTER AND IS INDICATED FOR USE IN THERAPEUTIC PLASMAFILTRATION IN DISEASES WHERE REMOVAL OF PLASMA COMPONENTS ARE INDICTED, INCLUDING PLASMAFILTRATION PROCEDURESWHERE FILTERED PLASMA IS REINFUSED

    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