BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Coronary

    PMA: P900043 · Supplement: S026 · Decision Apr 6, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    BX VELOCITY STENT ON RAPTOR RAIL STENT DELIVERY SYSTEM (RX)
    PMA Number
    P900043
    Supplement Number
    S026
    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
    April 6, 2001
    Date Received
    December 4, 2000
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MIDIFIED STENT/DELIVERY SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BX VELOCITY(TM) STENT ON RAPTORRAIL(TM) STENT DELIVERY SYSTEM (RX) AND IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE TREATMENT OF ABRUPT OR THREATENED VESSEL CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS (<= 30 MM IN LENGTH) WITH REFERENCE DIAMETERS IN THE RANGE OF 2.25 MM TO 4.00 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