BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

    PMA: P830063 · Supplement: S004 · Decision May 10, 2002
    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 PRISM TPE 2000 SET WITH PLASMAFILTER PF2000N
    PMA Number
    P830063
    Supplement Number
    S004
    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 10, 2002
    Date Received
    November 13, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE PERMANENT BONDING OF TUBING LINES ONTO THE PLASMAFILTER PF2000N. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PRISM TPE 2000 SET, AND IS INDICATED FOR USE IN PERFORMING THERAPEUTIC PLASMA SEPARATION FROM WHOLE BLOOD IN A CLINICAL SETTING TO REMOVE CIRCULATING 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