BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Coronary Drug-Eluting Stent

    PMA: P100023 · Supplement: S015 · Decision Feb 22, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32

    Basic Information

    Device Name
    Coronary Drug-Eluting Stent
    Trade Name
    ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)
    PMA Number
    P100023
    Supplement Number
    S015
    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
    February 22, 2012
    Date Received
    July 15, 2011
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    12M-0208

    Advisory Committee Statement

    APPROVAL TO EXPAND THE LABELED INDICATIONS FOR THE ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE). THE ION STENT SYSTEM IS INDICATED FOR IMPROVING LUMINAL DIAMETER: 1) FOR THE TREATMENT OF DE NOVO LESIONS IN NATIVE CORONARY ARTERIES 2.25 MM TO 4.00 MM IN DIAMETER IN LESIONS <= 34 MM IN LENGTH; OR 2) IN PATIENTS UNDERGOING PRIMARY ANGIOPLASTY TO TREAT ACUTE ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION, TRUE POSTERIOR MYOCARDIAL INFARCTION, OR PRESUMED NEW LEFT BUNDLE BRANCH BLOCK WITH SYMPTOMS OF ACUTE MYOCARDIAL INFARCTION LASTING > 20 MINUTES AND > 12 HOURS IN DURATION.

    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