BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Coronary Drug-Eluting Stent

    PMA: P160043 · Supplement: S073 · Decision Oct 12, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32

    Basic Information

    Device Name
    Coronary Drug-Eluting Stent
    Trade Name
    Resolute Onyx Over The Wire Zotarolimus-Eluting Coronary Stent System, Resolute Onyx Frontier Rapid Exchange Zotarolimus
    PMA Number
    P160043
    Supplement Number
    S073
    Device Class
    FDA Class 3
    Product Code
    NIQ
    Generic Name
    Coronary drug-eluting stent
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 12, 2023
    Date Received
    September 28, 2023
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    removal of operators’ hands/gloves testing from the environmental monitoring program for all devices, manufactured at Medtronic Ireland in controlled environment areas meeting ISO Class 8 requirements

    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