BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Coronary

    PMA: P030009 · Supplement: S008 · Decision Dec 8, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    VASCULAR DRIVER MX2 CORONARY STENT SYSTEM& MIRCODRIVER MX2 CORONARY STENT SYSTEM
    PMA Number
    P030009
    Supplement Number
    S008
    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
    December 8, 2006
    Date Received
    November 27, 2006
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF A WARNING, WHICH WILL INFORM THE PHYSICIAN OF THE POTENTIAL VESSEL WALL DAMAGE THAT COULD OCCUR IF FLUOROSCOPY IS NOT USED DURING WIRE INTERCHANGE, AND AN UPDATE OF THE GUIDE WIRE INTERCHANGE INSTRUCTIONS TO ENSURE THAT PHYSICIANS USE HIGH QUALITY FLUOROSCOPY TO DETERMINE GUIDE WIRE POSITION BEFORE ADVANCING INTO THE CORONARY ARTERIES.

    Classifications

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

    Product Code Device Name
    MAF Stent, Coronary