BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Coronary

    PMA: P030009 · Supplement: S020 · Decision Oct 22, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    MICRO-DRIVER RAPID EXCHANGE (RX) CORONARY STENT SYSTEM
    PMA Number
    P030009
    Supplement Number
    S020
    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
    October 22, 2008
    Date Received
    March 31, 2008
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF THE MICRO-DRIVER RAPID EXCHANGE DELIVERY PLATFORMAND THE ADDITION OF THE MEDTRONIC MEXICO FACILITY IN TIJUANA FOR THE MANUFACTURING OF CATHETERSUB-ASSEMBLIES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MICRO-DRIVERRAPID EXCHANGE (RX) CORONARY STENT SYSTEM AND IS 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