BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Agent, Absorbable Hemostatic, Collagen Based

    PMA: P050044 · Supplement: S023 · Decision Sep 25, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Agent, Absorbable Hemostatic, Collagen Based
    Trade Name
    VITAPREP PLASMA SEPERATOR
    PMA Number
    P050044
    Supplement Number
    S023
    Device Class
    FDA Class 3
    Product Code
    LMF
    Generic Name
    Agent, absorbable hemostatic, collagen based
    Regulation Number
    878.4490
    Medical Specialty
    General, Plastic Surgery
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 25, 2012
    Date Received
    August 29, 2012
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING TWO CHANGES TO THE LABELING INSTRUCTIONS FOR USE FOR THE VITAPREP PLASMA SEPARATOR: 1) INCLUSION OF WARNING STATEMENT: "ALWAYS WEAR WELL FITTING GLOVES WHEN HANDLING VITAPREP¿ AND 2) INCLUSION OF INSTRUCTIONS: "ASSURE THERE IS NO BLOOD IN THE LUER CONNECTION. IF BLOOD IS PRESENT, CAREFULLY CLEAR THE AREA OF RESIDUAL BLOOD.¿

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LMF Agent, Absorbable Hemostatic, Collagen Based