BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Laser, Transmyocardial Revascularization

    PMA: P950015 · Supplement: S008 · Decision Jan 29, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    System, Laser, Transmyocardial Revascularization
    Trade Name
    HEART LASER 2 (HL2)
    PMA Number
    P950015
    Supplement Number
    S008
    Device Class
    FDA Class 3
    Product Code
    MNO
    Generic Name
    SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 29, 2001
    Date Received
    September 28, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MANUFACTURING CHANGE TO UP-DATE THE LASER CONSOLE PORTION OF THE DEVICE SYSTEM FROM THE CURRENTLY APPROVED HL1 (HEART LASER(TM)) TO THE HL2 (HEAR LASER 2). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HEART LASER 2 (HL2), AND IS INDICATED FOR USE IN THE TREATMENT OF PATIENTS WITH STABLE ANGINA (CANADIAN CARDIOVASCULAR SOCIETY CLASS 3 OR 4) REFRACTORY TO MEDICAL TREATMENT AND SECONDARY TO OBJECTIVELY DEMONSTRATED CORONARY ARTERY ATHEROSCLEROSIS AND WITH A REGION OF THE MYOCARDIUM NOT AMENABLE TO DIRECT CORONARY REVASCULARIZATION.

    Classifications

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

    Product Code Device Name
    MNO System, Laser, Transmyocardial Revascularization