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

    System, Endovascular Graft, Aortic Aneurysm Treatment

    PMA: P070007 · Supplement: S019 · Decision Jul 1, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    System, Endovascular Graft, Aortic Aneurysm Treatment
    Trade Name
    TALENT THORACIC STENT GRAFT SYSTEM
    PMA Number
    P070007
    Supplement Number
    S019
    Device Class
    FDA Class 3
    Product Code
    MIH
    Generic Name
    SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    July 1, 2010
    Date Received
    June 4, 2010
    Supplement Type
    30-Day Notice
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE TO INTRODUCE THE MICROVU MEASUREMENT SYSTEM FOR THE DIMENSIONAL MEASUREMENTS OF EXTRUDED TUBING.

    Classifications

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

    Product Code Device Name
    MIH System, Endovascular Graft, Aortic Aneurysm Treatment