BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Agent, Absorbable Hemostatic, Non-Collagen Based

    PMA: N12159 · Supplement: S030 · Decision Apr 26, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29

    Basic Information

    Device Name
    Agent, Absorbable Hemostatic, Non-Collagen Based
    Trade Name
    SURGICAL SNOW ABSORBABLE HEMOSTAT
    PMA Number
    N12159
    Supplement Number
    S030
    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
    April 26, 2012
    Date Received
    March 9, 2012
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR LABELING CHANGES INCLUDING UPDATED GRAPHICS, INSTRUCTIONS FOR USE, AND LANGUAGE TRANSLATIONS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SURGICEL SNOW ABSORBABLE HEMOSTAT AND IS INDICATED FOR: SURGICEL ABSORBABLE HEMOSTAT (OXIDIZED REGENERATED CELLULOSE) IS USED ADJUNCTIVELY IN SURGICAL PROCEDURES TO ASSIST IN THE CONTROL OF CAPILLARY, VENOUS, AND SMALL ARTERIAL HEMORRHAGE WHEN LIGATION OR OTHER CONVENTIONAL METHODS OF CONTROL ARC IMPRACTICAL OR INEFFECTIVE. SURGICEL ORIGINAL, SURGICEL FIBRILLAR, SURGICEL NUKNIT AND SURGICEL SNOW HEMOSTATS CAN BE CUT TO SIZE FOR USE IN ENDOSCOPIC PROCEDURES. SURGICEL ABSORBABLE HEMOSTAT (OXIDIZED REGENERATED CELLULOSE) IS INDICATED FOR ADJUNCTIVE USE TO ASSIST IN THE CONTROL OF BLEEDING IN EXODONTIA AND ORAL SURGERY. IT MAY ALSO BE USED TO HELP ACHIEVE HEMOSTASIS AFTER SINGLE OR MULTIPLE TOOTH EXTRACTIONS, ALVEOLOPLASTY, GINGIVAL HEMORRHAGE, IMPACTIONS, BIOPSIES, AND OTHER PROCEDURES IN THE ORAL CAVITY.

    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