BEUDAMED
    FDA PMA Approved (Withdrawn) 🇺🇸 United States

    PMA: P980017 · Decision Sep 25, 1998
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    PERMA-SEAL DIALYSIS ACCESS GRAFT MODEL 2C20
    PMA Number
    P980017
    Advisory Committee
    Cardiovascular
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    September 25, 1998
    Date Received
    December 12, 1997
    Expedited Review
    Y
    Docket Number
    98M-0835

    Advisory Committee Statement

    Approval for the Possis Perma-Seal(R) Dialysis Access Graft, Model 2C20-B. This device is indicated for use as a subcutaneous arteriovenous shunt graft to provide immediate and subsequent chronic blood access for high-efficiency hemodialysis in patients who meet one or more of the following conditons: 1) central venous cannulation is deemed hazardous or is technically unavailable; 2) are being maintained on chronic anticoagulation or antithrombotic therapy; and/or 3) are morbidly obese.