BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Coronary Drug-Eluting Stent

    PMA: P110019 · Supplement: S070 · Decision Sep 3, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32

    Basic Information

    Device Name
    Coronary Drug-Eluting Stent
    Trade Name
    XIENCE ALPINE RX & OTW EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
    PMA Number
    P110019
    Supplement Number
    S070
    Device Class
    FDA Class 3
    Product Code
    NIQ
    Generic Name
    Coronary drug-eluting stent
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 3, 2014
    Date Received
    June 4, 2014
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO CHANGE THE DISTAL BALLOON SHAFT, DISTAL OUTER MEMBER AND PROXIMAL HYPOTUBE COMPONENTS FOR THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM. YOU INDICATED THAT UPON IMPLEMENTATION OF THESE CHANGES, THE NEW NAME FOR THE CORONARY STENT SYSTEM WILL BE THE XIENCE ALPINE¿ EVEROLIMUS ELUTING CORONARY STENT SYSTEM.

    Classifications

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

    Product Code Device Name
    NIQ Coronary Drug-Eluting Stent