BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Ligament, Ptfe

    PMA: P850074 · Supplement: S008 · Decision Mar 3, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Prosthesis, Ligament, Ptfe
    Trade Name
    GORE-TEX{TM} CRUCIATE LIGAMENT PROSTHESIS
    PMA Number
    P850074
    Supplement Number
    S008
    Device Class
    FDA Class 3
    Product Code
    LWA
    Generic Name
    PROSTHESIS, LIGAMENT, PTFE
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 3, 1993
    Date Received
    December 13, 1991
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Classifications

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

    Product Code Device Name
    LWA Prosthesis, Ligament, Ptfe