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

    Absorbable Collagen Hemostatic Agent With Thrombin

    PMA: P050044 · Supplement: S033 · Decision Mar 2, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Absorbable Collagen Hemostatic Agent With Thrombin
    Trade Name
    VITAGEL RT3 SUTGICAL HEMOSTAT
    PMA Number
    P050044
    Supplement Number
    S033
    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
    March 2, 2017
    Date Received
    January 31, 2017
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    New tray tooling fixture, new sealing parameters and increased outer tray dimensions.

    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