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

    Agent, Absorbable Hemostatic, Collagen Based

    PMA: N17600 · Supplement: S021 · Decision Oct 29, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Agent, Absorbable Hemostatic, Collagen Based
    Trade Name
    AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT(MCH) FLOUR
    PMA Number
    N17600
    Supplement Number
    S021
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 29, 2004
    Date Received
    October 4, 2004
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ELIMINATION AND MODIFICATION OF THE ENDOTOXIN TESTING AND MODIFICATION OF THE LIT SEAL STRENGTH TESTING AND MODIFICATION OF THE FOIL POUCH SEAL STRENGTH TESTING.

    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