BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P060002 · Supplement: S002 · Decision Oct 28, 2008
    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 WITH OPTIMIZED DELIVERY SYSTEM
    PMA Number
    P060002
    Supplement Number
    S002
    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 28, 2008
    Date Received
    March 20, 2008
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE OPTIMIZED DELIVERY SYSTEM, THE TRANSFER OF MANUFACTURING OF THE DELIVERY SYSTEM TO ANGIOMED GMBH & CO., KARLSRUHE, GERMANY, AND THE TRANSFER OF STERILIZATION TO BARD MEDICAL DIVISION REGIONAL STERILIZATION AND REGIONAL STERILIZATION MADISON OPERATION, IN COVINGTON, GEORGIA, AND MADISON, GEORGIA, RESPECTIVELY.

    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