BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Iliac

    PMA: P050017 · Supplement: S002 · Decision Feb 3, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    Stent, Iliac
    Trade Name
    ZILVER VASCULAR STENT
    PMA Number
    P050017
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    NIO
    Generic Name
    STENT, ILIAC
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 3, 2009
    Date Received
    March 10, 2008
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MANUFACTURING SITE LOCATED AT COOK IRELAND, LTD., LIMERICK, IRELAND FOR MANUFACTURING AND FINAL MANUFACTURING TO INCLUDE LABELING AND PACKAGING, AND FOR A STERILIZATION SITE LOCATED AT ISOTRON IRELAND, LTD., TULLAMORE, IRELAND.

    Classifications

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

    Product Code Device Name
    NIO Stent, Iliac