|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 PRESCRIPTION INSERTS|
|Classification Name||implant, corneal, refractive|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for 0. 275 mm and 0. 325 mm intacs(tm) as well as for a new trade name, "intacs(tm) prescription inserts. ".