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

    Agent, Absorbable Hemostatic, Collagen Based

    PMA: P850010 · Supplement: S071 · Decision Jun 22, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Agent, Absorbable Hemostatic, Collagen Based
    Trade Name
    HELISTAT,HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
    PMA Number
    P850010
    Supplement Number
    S071
    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
    June 22, 2016
    Date Received
    May 25, 2016
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Create a new procedure, Cutting and Inspection Procedure - ACS, for the cutting and inspection of Absorbable Collagen Sponge (ACS)-(EU) used as a component of the InductOs marketed in the European Union (EU) product in room 304, 105 Morgan Lane, Plainsboro, New Jersey. This procedure directs operators to cull out and reject any cut collagen sponge that has visible foreign matter embedded in or on the surface of the collagen sponge during the inspection process. In addition, a procedure, Packaging of ACS Sponge 3”x 4” or 1”x 2” 6-Pack or 1”x 2” 2-Packs on the Belco Sealer # 2, has been revised to direct operators to reject packaged product that has visible foreign matter on the product or inside the primary or secondary packaging.

    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