BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Superficial Femoral Artery

    PMA: P120002 · Decision Nov 7, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37

    Basic Information

    Device Name
    Stent, Superficial Femoral Artery
    Trade Name
    SMA RT CONTROL AND SMART VASCULAR STENT SYSTEMS
    PMA Number
    P120002
    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
    November 7, 2012
    Date Received
    February 3, 2012
    Expedited Review
    N
    Docket Number
    12M-1183

    Advisory Committee Statement

    APPROVAL FOR THE S.M.A.R.T. CONTROL AND S.M.A.R.T. VASCULAR STENT SYSTEMS. THIS DEVICE IS INDICATED FOR USE TO IMPROVE LUMINAL DIAMETER IN THE TREATMENT OF PATIENTS WITH DE NOVO OR RESTENOTIC NATIVE LESION(S) OF THE SUPERFICIAL FEMORAL ARTERY AND/OR PROXIMAL POPLITEAL ARTERY WITH TOTAL LENGTH UP TO 150 MM AND WITH A REFERENCE VESSEL DIAMETER RANGING FROM 4 MM TO 7 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