BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Absorbable Collagen Hemostatic Agent With Thrombin

    PMA: P990009 · Supplement: S045 · Decision Jan 4, 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 MATRIX HEMOSTATIC SEALANT
    PMA Number
    P990009
    Supplement Number
    S045
    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
    January 4, 2017
    Date Received
    December 5, 2016
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for modification to the Instructions for Use to add clarity that the removal of excess product is done to avoid excessive inflammatory reaction, adhesion and/or granuloma formation.

    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