BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Absorbable Collagen Hemostatic Agent With Thrombin

    PMA: P990009 · Supplement: S044 · Decision Feb 10, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Absorbable Collagen Hemostatic Agent With Thrombin
    Trade Name
    FLOSEAL HEMOSTATIC MATRIX
    PMA Number
    P990009
    Supplement Number
    S044
    Device Class
    FDA Class 3
    Product Code
    PMX
    Generic Name
    Absorbable collagen hemostatic agent with thrombin
    Regulation Number
    878.4490
    Medical Specialty
    General, Plastic Surgery
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 10, 2017
    Date Received
    November 2, 2016
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for modifications to the device design, material, labeling, and packaging, including: replacement of the 10 mL syringe assembly to align with the current 5 mL syringe design, removal of bowel for thrombin, removal of thrombin stickers, removal of malleable tip applicator (10 mL configuration only), removal of luer connector (10 mL configuration only), modification to the needle-free vial access device (VAD), incorporation of thrombin pouch assembly, modification of diluent container, removal of plastic component tray, modification to kit box (5 mL configuration only), and labeling modifications corresponding to the aforementioned modifications.

    Classifications

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

    Product Code Device Name
    PMX Absorbable Collagen Hemostatic Agent With Thrombin