|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|| Special Supplement|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for two specific additional quality control inspection steps during the manufacturing of the sologrip handpiece and the addition of specific language in three places to the instructions for use for the sologrip handpiece.