BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Suture, Nonabsorbable, Silk

    PMA: N80989 · Supplement: S001 · Decision Apr 24, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    128
    Registration Numbers
    128

    Basic Information

    Device Name
    Suture, Nonabsorbable, Silk
    Trade Name
    SILK SUTURES
    PMA Number
    N80989
    Supplement Number
    S001
    Device Class
    FDA Class 2
    Product Code
    GAP
    Generic Name
    Suture, nonabsorbable, silk
    Regulation Number
    878.5030
    Medical Specialty
    General, Plastic Surgery
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 24, 1987
    Date Received
    March 6, 1987
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Classifications

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

    Product Code Device Name
    GAP Suture, Nonabsorbable, Silk