|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||INTACS CORNEAL IMPLANTS|
|Classification Name||implant, corneal, refractive|
|Supplement Type||135 review track for 30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Transfer of distribution, product release, secondary labeling and packaging, and limited secondary labeling and secondary packaging rework operations from the firms current facility to its new facility.