BEUDAMED
    FDA PMA Approved (Withdrawn) 🇺🇸 United States

    PMA: P960031 · Decision Jun 23, 1997
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    PERIOGARD PERIODONTAL TISSUE MONITOR
    PMA Number
    P960031
    Advisory Committee
    Clinical Chemistry
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    June 23, 1997
    Date Received
    September 19, 1996
    Expedited Review
    N
    Docket Number
    98M-0036

    Advisory Committee Statement

    APPROVAL FOR THE PERIOGARD PERIODONTAL TISSUE MONITOR (PTM). THIS DEVICE IS INDICATED FOR USE AS A RAPID, CHAIR-SIDE, VISUAL TEST FOR THE QUALITATIVE DETERMINATION OF ASPARTATE AMINOTRANSFERASE (AST) IN GINGIVAL CREVICULAR FLUID. THE PTM KIT DETECTS ELEVATED LEVELS OF AST ASSOCAITED WITH TISSUE NECROSIS. IT IS INTENDED TO BE USED AS AN OBJECTIVE, BIOCHEMICAL ADJUNCT TO TRADITIONAL METHODS OF MONITORING PATIENTS TO ASSIST IN THE DECISION TO APPLY TREATMENT AND IN THE EVALUATION OF TREATMENT EFFECTIVENESS.