|Trade Name||ECLIPSE TMR HOLMIUM LASER SYSTEM|
|Classification Name||system, laser, transmyocardial revascularization|
|Generic Name||holmium laser system fiber optic delivery system handpiece|
|Supplement Type||normal 180 day track|
|Supplement Reason|| postapproval protocol or modification to a protocol|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a proposed post-approval study protocol. In addition, all advertising and promotional materials must include the warning aobut the use of tmr in a patient with unstable angina, the need for patients to sign a consent form and the requirements that apply to the training of practitioners who may use the device.