BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Suture, Nonabsorbable, Synthetic, Polypropylene

    PMA: P820083 · Supplement: S024 · Decision Oct 3, 1996
    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
    S024
    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
    October 3, 1996
    Date Received
    September 18, 1996
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF TWO NEW INDICATIONS: FOR USE IN THE REPAIR OF DURA MATER AND FOR USE I THE REPAIR OFREPLACEMENT OF CHORDAE TENDINEAE

    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