BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Suture, Nonabsorbable

    PMA: N12815 · Supplement: S021 · Decision Jun 18, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Suture, Nonabsorbable
    Trade Name
    MERSILENE*POLYESTER SUTURE
    PMA Number
    N12815
    Supplement Number
    S021
    Device Class
    FDA Class 2
    Product Code
    GAO
    Generic Name
    Suture, nonabsorbable
    Regulation Number
    878.4495
    Medical Specialty
    General, Plastic Surgery
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 18, 1987
    Date Received
    February 5, 1987
    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
    GAO Suture, Nonabsorbable