BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Glenoid Fossa Prosthesis

    PMA: P000035 · Supplement: S006 · Decision Jan 31, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Glenoid Fossa Prosthesis
    Trade Name
    TMJ FOSSA-EMINENCE PROSTHESIS SYSTEM
    PMA Number
    P000035
    Supplement Number
    S006
    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
    January 31, 2012
    Date Received
    May 11, 2011
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR LABELING CHANGES TO UPDATE THE OWNER AND COMPANY NAME, MANUFACTURING SUITE, STANDARDIZATION OF THE PRODUCT NAMES, AND ADVERSE EVENTS SECTION RELATED TO COMPLETION OF THE POST-APPROVAL STUDY.

    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