BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Superficial Femoral Artery

    PMA: P120020 · Decision Mar 28, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37

    Basic Information

    Device Name
    Stent, Superficial Femoral Artery
    Trade Name
    SUPERA PERIPHERAL STENT SYSTEM
    PMA Number
    P120020
    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
    March 28, 2014
    Date Received
    November 16, 2012
    Expedited Review
    N
    Docket Number
    14M-0434

    Advisory Committee Statement

    APPROVAL FOR THE SUPERA® PERIPHERAL STENT SYSTEM. THIS DEVICE IS INDICATED TO IMPROVE LUMINAL DIAMETER IN THE TREATMENT OF PATIENTS WITH SYMPTOMATIC DE NOVO OR RESTENOTIC NATIVE LESIONS OR OCCLUSIONS OF THE SUPERFICIAL FEMORAL ARTERY (SFA) AND/OR PROXIMAL POPLITEAL ARTERY, WITH REFERENCE VESSEL DIAMETERS OF 4.0 TO 6.5 MM, AND LESION LENGTHS UP TO 140 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