BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

    PMA: P830063 · Supplement: S015 · Decision Mar 25, 2020
    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 TPE2000 Set
    PMA Number
    P830063
    Supplement Number
    S015
    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
    March 25, 2020
    Date Received
    February 24, 2020
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the following changes in the instructions for use:1) A labeling change to align the sterile symbol to current sterile fluid path description in the instructions for use of the Prismaflex TPE2000 set; and2) The addition of the following warning statement: Use only drugs compatible with plastics listed in the specifications section. Some plastics can be incompatible with drugs when in contact with solutions with pH > 10.

    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