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

    Coronary Drug-Eluting Stent

    PMA: P150003 · Supplement: S030 · Decision May 26, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32

    Basic Information

    Device Name
    Coronary Drug-Eluting Stent
    Trade Name
    Synergy Everolimus-Eluting Platinum Chromium Coronary Stent System
    PMA Number
    P150003
    Supplement Number
    S030
    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
    May 26, 2017
    Date Received
    April 28, 2017
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Updates to the Programmable Logic Controller (PLC) software used for sterilization Chamber 3, an update to the vacuum pump system used in Chamber 3, and an update to the validation documentation structure used to support the 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