BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Agent, Absorbable Hemostatic, Non-Collagen Based

    PMA: N12159 · Supplement: S013 · Decision Jan 16, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29

    Basic Information

    Device Name
    Agent, Absorbable Hemostatic, Non-Collagen Based
    Trade Name
    SURGICEL*/SURGICEL NU-KNIT* ABSORBABLE HEMOSTAT
    PMA Number
    N12159
    Supplement Number
    S013
    Device Class
    FDA Class 3
    Product Code
    LMG
    Generic Name
    Agent, absorbable hemostatic, non-collagen based
    Regulation Number
    878.4490
    Medical Specialty
    General, Plastic Surgery
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 16, 1996
    Date Received
    September 15, 1993
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL 1)PROCESS CHANGE THAT DELETES THE USE OF THE IN-PROCESS SOLVENT FREON AND REPLACES IT WITH PERFLUOROHEXANE 2) CHANGE OF IN-PROCESS MANUFACTURING FACILITY TO NORAMCO, INC., 1440 OLYMPIC DR., P.O. BOX 800001, ATHENS, GA 30608-8001 3)CHANGE OF QUALITY ASSURANCE SITE TO, JOHNSON AND JOHNSON MEDICAL, INC., U.S. HIGHWAY 75S AND 1417W, SHERMAN, TX 75091-9100 4)ADDITION OF ALTERNATE STERILIZATION SITE, JOHNSON & JOHNSON MEDICAL, INC., U.S. HIGHWAY 75S AND 1417W, SHERMAN, TX 75091-9100

    Classifications

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

    Product Code Device Name
    LMG Agent, Absorbable Hemostatic, Non-Collagen Based