BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Coronary Drug-Eluting Stent

    PMA: P110019 · Supplement: S018 · Decision Oct 5, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32

    Basic Information

    Device Name
    Coronary Drug-Eluting Stent
    Trade Name
    XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM & XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM
    PMA Number
    P110019
    Supplement Number
    S018
    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
    October 5, 2012
    Date Received
    May 29, 2012
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO ALLOW THE CORRESPONDING DRUG CONTENT VALUES TO BE CENTERED AROUND 100% LABEL CLAIM AND PROVIDE INCREASED PROBABILITY THAT INDIVIDUAL UNITS WILL HAVE A DRUG CONTENT OF GREATER THAN 90% OF THE LABELED CLAIM TO MEET THE CONDITION OF APPROVAL THAT "WITHIN 12 MONTHS OF PMA APPROVAL, YOU SHOULD SUBMIT A PMA SUPPLEMENT REQUESTING APPROVAL TO TIGHTEN THE IN-PROCESS COATING WEIGHT GAIN SPECIFICATION OR IMPLEMENT PROCEDURES TO RE-COAT STENTS WITH LESS THAN 95% COATING WEIGHT GAIN UPON IN-PROCESS INSPECTION. THE COMPANY HAS PROVIDED THE ALTERNATIVE SOLUTION.

    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