BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

    PMA: P130029 · Decision Jun 17, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14

    Basic Information

    Device Name
    System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
    Trade Name
    FLUENCY PLUS ENDOVASCULAR STENT GRAFT
    PMA Number
    P130029
    Device Class
    FDA Class 3
    Product Code
    PFV
    Generic Name
    System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 17, 2014
    Date Received
    December 17, 2013
    Expedited Review
    N
    Docket Number
    14M-0875

    Advisory Committee Statement

    APPROVAL FOR THE FLUENCY PLUS ENDOVASCULAR STENT GRAFT. THIS DEVICE IS INDICATED FOR USE IN THE TREATMENT OF IN-STENT RESTENOSIS IN THE VENOUS OUTFLOW OF HEMODIALYSIS PATIENTS DIALYZING BY EITHER AN ARTERIOVENOUS(AV) FISTULA OR AV GRAFT.

    Classifications

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

    Product Code Device Name
    PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment