BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Suture, Nonabsorbable, Synthetic, Polyamide

    PMA: N80838 · Supplement: S015 · Decision Jun 8, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    120
    Registration Numbers
    120

    Basic Information

    Device Name
    Suture, Nonabsorbable, Synthetic, Polyamide
    Trade Name
    SUPRAMID EXTRA SUTURES
    PMA Number
    N80838
    Supplement Number
    S015
    Device Class
    FDA Class 2
    Product Code
    GAR
    Generic Name
    Suture, nonabsorbable, synthetic, polyamide
    Regulation Number
    878.5020
    Medical Specialty
    General, Plastic Surgery
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 8, 1989
    Date Received
    May 1, 1989
    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
    GAR Suture, Nonabsorbable, Synthetic, Polyamide