BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Coronary

    PMA: P970035 · Supplement: S011 · Decision Jun 3, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    GFX SL OVER-THE-WIRE CORONARY STENT SYSTEM
    PMA Number
    P970035
    Supplement Number
    S011
    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
    June 3, 1999
    Date Received
    November 12, 1998
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the Medtronic AVE S540(TM) Over-The_Wire Coronary Stent System. The device is indicated for improving coronary luminal diameter in the treatment of acute or threatened closure during a planned interventional procedure in de novo lesions (length <24 mm) within a native coronary artery or arterial bypass graft conduit with a reference diameter between 2.2 and 2.9mm. Long term outcome (beyond 30 days) 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