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

    Absorbable Collagen Hemostatic Agent With Thrombin

    PMA: P990009 · Supplement: S073 · Decision Jan 10, 2024
    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
    S073
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    January 10, 2024
    Date Received
    December 13, 2023
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    change in automation in the syringe filling, syringe capping and torqueing steps

    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