BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Coronary

    PMA: P030009 · Supplement: S039 · Decision Sep 14, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    INTEGRITY CORONARY STENT SYSTEM
    PMA Number
    P030009
    Supplement Number
    S039
    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
    September 14, 2010
    Date Received
    February 12, 2010
    Supplement Type
    Normal 180 Day Track
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE INTEGRITY CORONARY STENT SYSTEM. THE DEVICE IS INDICATED FOR IMPROVINGCORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC LESIONS, WITH REFERENCE VESSEL DIAMETERS OF 2.25-4.0 MM AND <=30 MM IN LENGTH, USING DIRECT STENTING OR PREDILATATION.

    Classifications

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

    Product Code Device Name
    MAF Stent, Coronary