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    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Stent, Coronary

    PMA: P970061 · Decision Jul 16, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    SCIMED RADIUS CORONARY STENT WITH DELIVERY SYSTEM
    PMA Number
    P970061
    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    Approved (Withdrawn)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
    July 16, 1998
    Date Received
    December 22, 1997
    Expedited Review
    N
    Docket Number
    99M-1980

    Advisory Committee Statement

    The device is indicated for use in patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions (length <30 mm) with a reference vessel diameter ranging from 2.75 mm to 4.25 mm and is intended to improve coronary luminal diameter. Long-term outcome (beyond 6 months) for this permanent implatn is unknown.

    Classifications

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

    Product Code Device Name
    MAF Stent, Coronary