BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Suture, Absorbable, Natural

    PMA: N84381 · Supplement: S008 · Decision Apr 28, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75

    Basic Information

    Device Name
    Suture, Absorbable, Natural
    Trade Name
    CHROMIC GUT SUTURE
    PMA Number
    N84381
    Supplement Number
    S008
    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
    April 28, 1988
    Date Received
    March 31, 1988
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    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