BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Agent, Absorbable Hemostatic, Collagen Based

    PMA: N18286 · Supplement: S032 · Decision Jul 2, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Agent, Absorbable Hemostatic, Collagen Based
    Trade Name
    Gel-Flow NT, Gelfoam Powder, Gelfoam Sponge, Gelfoam Compressed Sponge
    PMA Number
    N18286
    Supplement Number
    S032
    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
    Approved
    Decision Code
    APPR
    Decision Date
    July 2, 2019
    Date Received
    June 6, 2019
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a change in the labeling to identify the potential risk of pseudotumor appearance associated with device use.

    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