|Trade Name||VISX EXCIMER LASER SYSTEM MODELS "B" AND "C"|
|Classification Name||excimer laser system|
|Generic Name||eximer laser for ophthalmic use|
|Supplement Type||normal 180 day track|
|Supplement Reason|| other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for revised protocol for post-approval study to detect and report rare but serious adverse event. *please note that long-term data must be reflected in the labeling (via a supplement to the pma) when the additional follow-ups and/or post-approval studies are completed.