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

    Agent, Absorbable Hemostatic, Non-Collagen Based

    PMA: N12159 · Supplement: S082 · Decision Aug 31, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29

    Basic Information

    Device Name
    Agent, Absorbable Hemostatic, Non-Collagen Based
    Trade Name
    SURGICEL ORIGINAL Absorbable Hemostat, SURGICEL Nu-Knit Absorbable Hemostat, SURGICEL Fibrillar Absorbable Hemostat, SUR
    PMA Number
    N12159
    Supplement Number
    S082
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    August 31, 2021
    Date Received
    August 2, 2021
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Expansion of the controlled manufacturing environment (CME) in the Ethicon, LLC, San Lorenzo, Puerto Rico facility.

    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