BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Suture, Nonabsorbable, Synthetic, Polypropylene

    PMA: P820083 · Supplement: S004 · Decision Aug 5, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    111
    Registration Numbers
    111

    Basic Information

    Device Name
    Suture, Nonabsorbable, Synthetic, Polypropylene
    Trade Name
    GORE-TEX(R) EXPANDED PTFE SUTURE
    PMA Number
    P820083
    Supplement Number
    S004
    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 5, 1986
    Date Received
    June 12, 1986
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    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