BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Coronary

    PMA: P910030 · Supplement: S005 · Decision May 12, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    GIANTURCO-ROUBIN CORONARY FLEX-STENT(TM) 12MM LONG
    PMA Number
    P910030
    Supplement Number
    S005
    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
    May 12, 1997
    Date Received
    November 26, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MODIFIED VERSION OF THE ORIGINAL GIANTURCO-ROUBIN CORONARY FLEX STENT(TM). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GR II(TM) CORONARY STENT AND IS INDICATED FOR TREATMENT OF ACUTE OR THREATENED CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN VESSELS WITH REFERENCE DIAMETERS IN THE RANGE OF 2.1 MM TO 4.0 MM.

    Classifications

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

    Product Code Device Name
    MAF Stent, Coronary