BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

    PMA: P820033 · Supplement: S017 · Decision Sep 30, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma
    Trade Name
    Plasmaflo OP-05W(A)
    PMA Number
    P820033
    Supplement Number
    S017
    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
    September 30, 2025
    Date Received
    February 6, 2024
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Your supplement requested approval for a change in the supplier of the lubricant, calcium stearate, added to the polyethylene resin used in the manufacture of the hollow fiber of the device.

    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