BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Glenoid Fossa Prosthesis

    PMA: P000035 · Supplement: S004 · Decision Oct 14, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Glenoid Fossa Prosthesis
    Trade Name
    TMJ FOSSA-EMINENCE/CONDYLAR PROSTHESIS SYSTEM AND TMJ FOSSA-EMINENCE PROSTHESIS
    PMA Number
    P000035
    Supplement Number
    S004
    Device Class
    FDA Class 3
    Product Code
    MPI
    Generic Name
    Glenoid fossa prosthesis
    Regulation Number
    872.3950
    Medical Specialty
    Dental
    Advisory Committee
    Dental
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 14, 2003
    Date Received
    December 26, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Other
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE PACKAGING/SHELF LIFE TESTING PROTOCOL TO EXTEND THE SHELF LIFE BEYOND 6 MONTHS.

    Classifications

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

    Product Code Device Name
    MPI Glenoid Fossa Prosthesis