BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

    PMA: P820033 · Supplement: S019 · Decision Apr 9, 2026
    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-05 W(A)
    PMA Number
    P820033
    Supplement Number
    S019
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 9, 2026
    Date Received
    March 13, 2026
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    a change in the acceptance criterion for the opening torque test performed during in-process inspection of the Plasmaflo™ OP-05W(A) filter

    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