BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Coronary

    PMA: P980009 · Supplement: S002 · Decision Jul 28, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    MAGIC WALLSTENT SELF-EXPANDING CORONARY STENT
    PMA Number
    P980009
    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
    July 28, 1999
    Date Received
    December 28, 1998
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    Y

    Advisory Committee Statement

    Approval to add an indication for the treatment of saphenous vein grafts. The device is now indicated for improving luminal diameter in the following: 1)pts w/symptomatic ischemic disease due to discrete de novo lesion in native coronary arteries (length < 35 mm) wiht a reference vessel diameter of 3.0 to 5.5 mm; 2) treatment of abrupt or threatened closure in patients with failed interventional therapy in lesions with reference diameters in the range of 3.0 to 5.5 mm. 3) Patients with symptomatic ischemic heart disease due to lesions in saphenous vein bypass grafts with lesions length < 35mm and reference vessel diameter in the range of 3.0 to 5.5mm.

    Classifications

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

    Product Code Device Name
    MAF Stent, Coronary