BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Superficial Femoral Artery

    PMA: P140028 · Decision Jul 21, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37

    Basic Information

    Device Name
    Stent, Superficial Femoral Artery
    Trade Name
    INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM
    PMA Number
    P140028
    Device Class
    FDA Class 3
    Product Code
    NIP
    Generic Name
    STENT, SUPERFICIAL FEMORAL ARTERY
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 21, 2015
    Date Received
    December 10, 2014
    Expedited Review
    N
    Docket Number
    15M-2618

    Advisory Committee Statement

    APPROVAL FOR THE INNOVA VASCULAR SELF-EXPANDING STENT SYSTEM. THIS DEVICE IS INDICATED FOR: THE INNOVA VASCULAR SELF-EXPANDING STENT SYSTEM IS INDICATED TO IMPROVE LUMINAL DIAMETER IN THE TREATMENT OF SYMPTOMATIC DE-NOVO OR RESTENOTIC LESIONS IN THE NATIVE SUPERFICIAL FEMORAL ARTERY (SFA) AND/OR PROXIMAL POPLITEAL ARTERY (PPA) WITH REFERENCE VESSEL DIAMETERS FROM 4.0 MM TO 7.0 MM AND LESION LENGTHS UP TO 190 MM.

    Classifications

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

    Product Code Device Name
    NIP Stent, Superficial Femoral Artery