BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Glenoid Fossa Prosthesis

    PMA: P000035 · Supplement: S003 · Decision Jan 22, 2004
    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
    PMA Number
    P000035
    Supplement Number
    S003
    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 22, 2004
    Date Received
    June 20, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A NEW MANUFACTURING SITE FOR THE CRYSTALCLEAR ANATOMICAL MODEL. THE SITE IS LOCATED AT TMJ IMPLANTS, INC., GOLDEN, COLORADO.

    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