BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

    PMA: P830063 · Supplement: S006 · Decision Jun 17, 2011
    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
    PRISMAFLEX TPE 2000 SET
    PMA Number
    P830063
    Supplement Number
    S006
    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
    June 17, 2011
    Date Received
    October 9, 2007
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE GAMBRO PRISMA TPE 2000 SET WITH PLASMAFILTER PF 2000N TO PERMIT THE USE OF THE PLASMAFILTER WITH THE GAMBRO PRISMAFLEX SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PRISMAFLEX TPE 2000 SET AND IS INDICATED FOR THERAPEUTIC PLASMAPHERESIS.

    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