|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||CARDIOGENESIS TMR SYSTEM|
|Classification Name||system, laser, transmyocardial revascularization|
|Generic Name||holmium laser system fiber optic delivery system handpiece|
|Supplement Type||30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Changes to the manufacturing of the handpiece delivery system.