BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Suture, Nonabsorbable, Synthetic, Polyester

    PMA: P840041 · Supplement: S004 · Decision Aug 8, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44

    Basic Information

    Device Name
    Suture, Nonabsorbable, Synthetic, Polyester
    Trade Name
    NOVAFIL(TM)
    PMA Number
    P840041
    Supplement Number
    S004
    Device Class
    FDA Class 2
    Product Code
    GAS
    Generic Name
    Suture, nonabsorbable, synthetic, polyester
    Regulation Number
    878.5000
    Medical Specialty
    General, Plastic Surgery
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 8, 1989
    Date Received
    June 9, 1989
    Supplement Type
    Normal 180 Day 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
    GAS Suture, Nonabsorbable, Synthetic, Polyester