BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Stent, Iliac

    PMA: P030045 · Supplement: S006 · Decision May 7, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    Stent, Iliac
    Trade Name
    lntraStent DoubleStrut Stent, Visi-Pro Balloon-Expandable Peripheral Stent System
    PMA Number
    P030045
    Supplement Number
    S006
    Device Class
    FDA Class 3
    Product Code
    NIO
    Generic Name
    STENT, ILIAC
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    May 7, 2021
    Date Received
    April 8, 2021
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    New sterilization cycle with a reduced EO concentration using Chamber 31 and Chamber 32 at contract sterilizer.

    Classifications

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

    Product Code Device Name
    NIO Stent, Iliac