BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Iliac

    PMA: P110035 · Supplement: S012 · Decision Jun 6, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    Stent, Iliac
    Trade Name
    EPIC VASCULAR SELF-EXPANDING STENT SYSTEM
    PMA Number
    P110035
    Supplement Number
    S012
    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
    June 6, 2013
    Date Received
    March 26, 2013
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE IN THE STENT LENGTH SPECIFICATION AND CHANGES TO THE PRODUCT LABELING WHICH INCLUDED A CHANGE TO THE LABELED LENGTH OF THE STENT AND MINOR EDITORIAL MODIFICATIONS.

    Classifications

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

    Product Code Device Name
    NIO Stent, Iliac