BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Coronary

    PMA: P030009 · Supplement: S054 · Decision Jun 9, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    INTEGRITY CORONARY STENT SYSTEMS
    PMA Number
    P030009
    Supplement Number
    S054
    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 9, 2011
    Date Received
    April 11, 2011
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR ADDITION OF LABELING REGARDING SIMULTANEOUS USE OF THE INTEGRITY RX STENT SYSTEM WITH EITHER ANOTHER INTEGRITY RX STENT SYSTEM, OR WITH A SPRINTER LEGEND RX BALLOON DILATION CATHETER. IN ADDITION, APPROVAL TO REVISE THE MRI COMPATIBILITY INFORMATION IN THE LABELING.

    Classifications

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

    Product Code Device Name
    MAF Stent, Coronary