BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Suture, Nonabsorbable, Synthetic, Polyethylene

    PMA: N16374 · Supplement: S034 · Decision Oct 7, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    233
    Registration Numbers
    233

    Basic Information

    Device Name
    Suture, Nonabsorbable, Synthetic, Polyethylene
    Trade Name
    PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S
    PMA Number
    N16374
    Supplement Number
    S034
    Device Class
    FDA Class 2
    Product Code
    GAT
    Generic Name
    Suture, nonabsorbable, synthetic, polyethylene
    Regulation Number
    878.5000
    Medical Specialty
    General, Plastic Surgery
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 7, 1988
    Date Received
    September 13, 1988
    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
    GAT Suture, Nonabsorbable, Synthetic, Polyethylene