|Trade Name||CARDIOGENESIS TMR SYSTEM|
|Classification Name||system, laser, transmyocardial revascularization|
|Generic Name||system, laser, transmyocardial revascularization|
|Supplement Type||special (immediate track)|
|Supplement Reason|| labeling change - indications/instructions/shelf life/tradename|
|Expedited Review Granted?|| No|
|Approval Order 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.