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

    Coronary Drug-Eluting Stent

    PMA: P070015 · Supplement: S078 · Decision Aug 25, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32

    Basic Information

    Device Name
    Coronary Drug-Eluting Stent
    Trade Name
    XIENCE NANO AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
    PMA Number
    P070015
    Supplement Number
    S078
    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
    August 25, 2011
    Date Received
    July 26, 2011
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    FOUR MANUFACTURING PROCESS CHANGES, WHICH HAVE BEEN PREVIOUSLY APPROVED FOR XIENCE V. THE CHANGES INCLUDED: (A) REMOVAL OF INITIAL CLEAN AND PLASMA TREATMENT; (B) REMOVAL OF DRUG FINAL WEIGH; (C) MODIFIED CLEAN ROOM GOWNING; AND (D) MODIFICATIONS TO THE SPRAY COATING PROCESS.

    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