BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    System, Laser, Transmyocardial Revascularization

    PMA: P970029 · Supplement: S030 · Decision Jun 23, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    System, Laser, Transmyocardial Revascularization
    Trade Name
    TMR HOLMIUM LASER SYSTEM
    PMA Number
    P970029
    Supplement Number
    S030
    Device Class
    FDA Class 3
    Product Code
    MNO
    Generic Name
    SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    June 23, 2016
    Date Received
    May 25, 2016
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Adding an incoming visual inspection to be conducted after sterilization and before shipping of the laser 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