BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Laser, Transmyocardial Revascularization

    PMA: P950015 · Supplement: S007 · Decision Sep 27, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    System, Laser, Transmyocardial Revascularization
    Trade Name
    THE HEART LASER(TM)CO2 TMR SYSTEM
    PMA Number
    P950015
    Supplement Number
    S007
    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
    September 27, 2000
    Date Received
    September 12, 2000
    Supplement Type
    Real-Time Process
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO MODIFY THE EXISTING POST-APPROVAL STUDY TO NO LONGER REQUIRE STUDY ENROLLMENT AT NEW SITES, AND TO LIMIT STUDY PARTICIPATION TO THOSE (EXISTING) SITES WHICH HAVE ENROLLED PATIENTS.

    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