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

    Stent, Coronary

    PMA: P020009 · Supplement: S119 · Decision Mar 25, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    EXPRESS MONORAIL AND OTW CORONARY STENT SYSTEM
    PMA Number
    P020009
    Supplement Number
    S119
    Device Class
    FDA Class 3
    Product Code
    MAF
    Generic Name
    STENT, CORONARY
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    March 25, 2014
    Date Received
    February 25, 2014
    Supplement Type
    30-Day Notice
    Expedited Review
    N

    Advisory Committee Statement

    ADD TWO ADDITIONAL INDIVIDUAL MOLDING STATION (IMS) BALLOON MOLDING TOWERS IN THE BALLOONS PRODUCTION AREA AT THE MAPLE GROVE FACILITY.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MAF Stent, Coronary