|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 RING SEGMENTS|
|Classification Name||implant, corneal, refractive|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
The 30-day notice requested the implementation of modifications made to the tumble polishing and final cleaning process used for the intacs corneal ring segments.