BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Stent, Superficial Femoral Artery

    PMA: P110040 · Decision Sep 19, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37

    Basic Information

    Device Name
    Stent, Superficial Femoral Artery
    Trade Name
    MEDTRONIC VASCULAR COMPLETE SE VASCULAR STENT SYSTEM
    PMA Number
    P110040
    Device Class
    FDA Class 3
    Product Code
    NIP
    Generic Name
    STENT, SUPERFICIAL FEMORAL ARTERY
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    September 19, 2013
    Date Received
    December 12, 2011
    Expedited Review
    N
    Docket Number
    13M-1159

    Advisory Committee Statement

    APPROVAL FOR THE MEDTRONIC VASCULAR COMPLETE SE VASCULAR STENT SYSTEM. THIS DEVICE IS INDICATED TO IMPROVE LUMINAL DIAMETER IN SYMPTOMATIC PATIENTS WITH DE NOVO AND/OR RESTENOTIC LESIONS OR OCCLUSIONS OF THE SUPERFICIAL FEMORAL ARTERY (SFA) OR PROXIMAL POPLITEAL ARTERY (PPA) WITH REFERENCE DIAMETERS RANGING FROM 4 MM TO 7 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