BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Laser, Transmyocardial Revascularization

    PMA: P970029 · Supplement: S026 · Decision May 7, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    System, Laser, Transmyocardial Revascularization
    Trade Name
    CARDIOGENESIS TMR SYSTEM
    PMA Number
    P970029
    Supplement Number
    S026
    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
    May 7, 2014
    Date Received
    April 9, 2014
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR INCLUDING THE POST APPROVAL STUDY LABELING CHANGES OF THE PEARL 8.0 DEVICE INTO THE INSTRUCTIONS FOR USE OF THE PEARL 5.0 AND THE SOLOGRIP III HANDPIECES AS WELL AS ADDING SOME CLARIFYING STATEMENTS TO ENSURE THE SAFE HANDLING OF THE HANDPIECES.

    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