BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Coronary

    PMA: P030009 · Supplement: S002 · Decision Apr 21, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    MICRO-DRIVER OVER-THE-WIRE CORONARY STENT SYSTEM AND MICRO-DRIVER MX2 CORONARY STENT SYSTEM
    PMA Number
    P030009
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    MAF
    Generic Name
    STENT, CORONARY
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 21, 2006
    Date Received
    July 14, 2004
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE MICRO-DRIVER OVER-THE-WIRE CORONARY STENT SYSTEM AND THE MICRO-DRIVER MX2 CORONARY STENT SYSTEM. THE SYSTEMS ARE INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO LESIONS WITH REFERENCE VESSEL DIAMETERS OF 2.25-2.75 MM AND <=21 MM IN LENGTH. OUTCOME BEYOND 270 DAYS FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT.

    Classifications

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

    Product Code Device Name
    MAF Stent, Coronary