BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Coronary Drug-Eluting Stent

    PMA: P110019 · Supplement: S047 · Decision Apr 23, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32

    Basic Information

    Device Name
    Coronary Drug-Eluting Stent
    Trade Name
    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM, SV
    PMA Number
    P110019
    Supplement Number
    S047
    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
    April 23, 2014
    Date Received
    May 22, 2013
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN UPDATE TO THE LABELING FOR THE XIENCE XPEDITION RX (RAPID EXCHANGE) AND OTW (OVER-THE-WIRE) TO CHANGE THE GUIDING CATHETER COMPATIBILITY FOR THE 4.0MM BALLOON DIAMETER SIZES FROM A MINIMUM OF A 6 FRENCH (F) GUIDE CATHETER TO 5F FOR THE 4.0 X 8-33MM SIZES.

    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