BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Superficial Femoral Artery

    PMA: P070014 · Supplement: S001 · Decision Jul 30, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37

    Basic Information

    Device Name
    Stent, Superficial Femoral Artery
    Trade Name
    LIFESTENT AND LIFESTENT XL VASCULAR STENT SYSTEMS
    PMA Number
    P070014
    Supplement Number
    S001
    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 30, 2009
    Date Received
    June 2, 2009
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO MODIFY THE NAME AND PACKAGE LABEL FOR THE LIFESTENTVASCULAR STENT SYSTEMS. SPECIFICALLY, THE WORD "FLEXSTAR" WILL BE REMOVED FROM THE TRADE NAMEAND "& BILIARY" WILL BE ADDED TO THE DEVICE PACKAGE LABELS TO REFLECT THE CLEARED BILIARY INDICATION FOR THIS DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LIFESTENTVASCULAR STENT SYSTEM AND LIFESTENT XL VASCULAR STENT SYSTEM AND IS INDICATED FORIMPROVEMENT OF LUMINAL DIAMETER IN THE TREATMENT OF DE-NOVO OR RESTENOTIC LESION IN THE NATIVESFA AND PROXIMAL POPLITEAL ARTERIES.

    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