BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Coronary

    PMA: P810046 · Supplement: S230 · Decision Jul 15, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    VOYAGER NC CORONARY DILATATION CATHETER
    PMA Number
    P810046
    Supplement Number
    S230
    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
    July 15, 2009
    Date Received
    April 1, 2009
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO MODIFY THE PROTECTIVE BALLOON SHEATH. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VOYAGER NC CORONARY DILATATION CATHETER AND IS INDICATED FOR: 1) BALLOON DILATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION; 2) BALLOON DILATION OF A CORONARY ARTERY OCCLUSION FOR THE PURPOSE OF RESTORING CORONARY FLOW IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION; AND 3) BALLOON DILATION OF A STENT AFTER IMPLANTATION.

    Classifications

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

    Product Code Device Name
    MAF Stent, Coronary