BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Suture, Nonabsorbable, Synthetic, Polypropylene

    PMA: P820083 · Supplement: S025 · Decision Aug 27, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    111
    Registration Numbers
    111

    Basic Information

    Device Name
    Suture, Nonabsorbable, Synthetic, Polypropylene
    Trade Name
    GORE-TEX(TM) SUTURE
    PMA Number
    P820083
    Supplement Number
    S025
    Device Class
    FDA Class 2
    Product Code
    GAW
    Generic Name
    Suture, nonabsorbable, synthetic, polypropylene
    Regulation Number
    878.5010
    Medical Specialty
    General, Plastic Surgery
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 27, 1998
    Date Received
    July 23, 1998
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for 1) a change in suture needle material 2) a change in suture needle geometry, and 3) addition of a silicone coating to the suture needle.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GAW Suture, Nonabsorbable, Synthetic, Polypropylene