BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

    PMA: P820033 · Supplement: S005 · Decision Mar 16, 2010
    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
    PLASMAFLO OP-05W (A)
    PMA Number
    P820033
    Supplement Number
    S005
    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 16, 2010
    Date Received
    August 18, 2009
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE PLASMAFLO OP-05W(A). THE DEVICE, IS INTENDED AS A REPLACEMENT FOR THE PLASMAFLO AP-05H AND THE PLASMAFLO AP-05H(L). THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME PLASMAFLO OP-05W(A) AND IS INDICATED FOR USE IN THERAPEUTIC PROCEDURES REQUIRING SEPARATION OF PLASMA FROM WHOLE BLOOD.

    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