BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

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

    PMA: P060002 · Decision Jul 23, 2007
    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
    FLAIR ENDOVASCULAR STENT GRAFT
    PMA Number
    P060002
    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    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    July 23, 2007
    Date Received
    January 17, 2006
    Expedited Review
    N
    Docket Number
    07M-0298

    Advisory Committee Statement

    APPROVAL FOR THE FLAIR ENDOVASCULAR STENT GRAFT. THE DEVICE IS INDICATED FOR USE IN THE TREATMENT OF STENOSES AT THE VENOUS ANASTOMOSIS OF EPTFE OR OTHER SYNTHETIC ARTERIOVENOUS (AV) ACCESS GRAFTS.

    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