BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Coronary

    PMA: P040016 · Supplement: S037 · Decision Sep 25, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    VERIFLEX FOR LIBERTE BARE METAL STENTS
    PMA Number
    P040016
    Supplement Number
    S037
    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 25, 2009
    Date Received
    September 15, 2009
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO ADD AN ALTERNATE TRADE NAME FOR THE LIBERTÉ MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEMS. THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME VERIFLEX BARE METAL CORONARY STENT AND IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC DISEASE WITH STENOTIC LESIONS IN NATIVE CORONARY ARTERIES (LENGTH <28 MM) WITH A REFERENCE VESSEL DIAMETER OF 2.75 TO 5.00 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