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    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Stent, Coronary

    PMA: P970035 · Decision Dec 23, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    AVE MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM AND AVE GFX OVER-THE-WIRE CORONARY STENT SYSTEM
    PMA Number
    P970035
    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    Approved (Withdrawn)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
    December 23, 1997
    Date Received
    August 5, 1997
    Expedited Review
    N
    Docket Number
    98M-0973

    Advisory Committee Statement

    Approval for the AVE Micro Stent(TM) II Over-the-Wire Coronary Stent System and the AVE GFX(TM) Over-the-Wire Coronary Stent System. The devices are indicated for use in patients eligible for balloon angioplasty with symptomatic ischemic disease due to discrete de novo lesions in native coronary arteries (length < 30 mm) with a reference vessel diameter of 3.0 mm to 4.0 mm. Stenting is intended to improve coronary luminal diameter (see Individualization of Treatment). Long term outcome (beyond 6 months) 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