BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Suture, Absorbable, Synthetic, Polyglycolic Acid

    PMA: N16881 · Supplement: S011 · Decision Nov 30, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    148
    Registration Numbers
    148

    Basic Information

    Device Name
    Suture, Absorbable, Synthetic, Polyglycolic Acid
    Trade Name
    DEXON
    PMA Number
    N16881
    Supplement Number
    S011
    Device Class
    FDA Class 2
    Product Code
    GAM
    Generic Name
    Suture, absorbable, synthetic, polyglycolic acid
    Regulation Number
    878.4493
    Medical Specialty
    General, Plastic Surgery
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 30, 1987
    Date Received
    October 14, 1987
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Classifications

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

    Product Code Device Name
    GAM Suture, Absorbable, Synthetic, Polyglycolic Acid