BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P060002 · Supplement: S028 · Decision Oct 4, 2012
    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
    Supplement Number
    S028
    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
    October 4, 2012
    Date Received
    September 27, 2012
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE INCORPORATION OF A NEW LEICA DM2500M MICROSCOPE AND DFC295 DIGITAL CAMERA TO INCREASE IMAGE RESOLUTION IN ORDER TO MEASURE MATERIAL POROSITY IN ACCORDANCE WITH ISO 7198.

    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