BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Suture, Absorbable, Natural

    PMA: N10389 · Supplement: S026 · Decision Oct 5, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75

    Basic Information

    Device Name
    Suture, Absorbable, Natural
    Trade Name
    ABSORBABLE SURGICAL SUTURE, USP
    PMA Number
    N10389
    Supplement Number
    S026
    Device Class
    FDA Class 2
    Product Code
    GAL
    Generic Name
    Suture, absorbable, natural
    Regulation Number
    878.4830
    Medical Specialty
    General, Plastic Surgery
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 5, 1987
    Date Received
    September 2, 1987
    Supplement Type
    Special (Immediate 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
    GAL Suture, Absorbable, Natural