BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Coronary Drug-Eluting Stent

    PMA: P070015 · Supplement: S139 · Decision Mar 5, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32

    Basic Information

    Device Name
    Coronary Drug-Eluting Stent
    Trade Name
    XIENCE V/nano Everolimus Eluting Coronary Stent System
    PMA Number
    P070015
    Supplement Number
    S139
    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
    March 5, 2018
    Date Received
    December 11, 2017
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for an alternate contract sterilizer site located at Synergy Heath Ireland Ltd, IDA Business & Technology Park, Sragh Industrial Estate, Tullamore, Co. Offaly, Ireland. To perform as an alternate ethylene oxide sterilization vendor for the GRAFTMASTER Coronary Stent Graft System, MULTI-LINK 8 Coronary, 8 LL Coronary, and 8 SV Coronary Stent System, XIENCE V and Nano Everolimus Eluting Coronary Stent System, and XIENCE Prime/Xpedition/Alpine/Sierra Everolimus Eluting Coronary Stent System (SV, LL).

    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