BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Stent, Coronary

    PMA: P980009 · Decision Sep 29, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    MAGIC WALLSTENT ENDOPROTHESIS
    PMA Number
    P980009
    Device Class
    FDA Class 3
    Product Code
    MAF
    Generic Name
    STENT, CORONARY
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    September 29, 1998
    Date Received
    April 1, 1998
    Expedited Review
    N
    Docket Number
    99M-2028

    Advisory Committee Statement

    Approval for the Magic WALLSTENT(R) Endoprosthesis. This device is indicated for improving coronary luminal diameter in the following: 1) patients with symptomatic ischemic disease due to discreter de novo lesions in native coronary arteries (length <35mm) with a reference vessel diameter of 3.0 to 5.5mm; 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 5.5mm.

    Classifications

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

    Product Code Device Name
    MAF Stent, Coronary