BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Bone Cement

    PMA: P960001 · Supplement: S008 · Decision Sep 1, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81

    Basic Information

    Device Name
    Bone Cement
    Trade Name
    DEPUY 1 AND ENDURANCE BONE CEMENTS
    PMA Number
    P960001
    Supplement Number
    S008
    Device Class
    FDA Class 2
    Product Code
    LOD
    Generic Name
    BONE CEMENT
    Regulation Number
    888.3027
    Medical Specialty
    Orthopedic
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 1, 1999
    Date Received
    May 19, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for minor labeling changes: 1) change the package insert labeling for DePuy 1 Bone Cement from multilingual to English only; and 2) change to the package labeling for DePuy 1 and Endurance Bone Cements to remove reference to pack sizes that are approved but not currently marketed.

    Classifications

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

    Product Code Device Name
    LOD Bone Cement