|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 (INTRASTROMAL 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 the view engineering voyage model v1212 dimensional non-contact measurement system for the inspection of thickness, width and symmetry of the intacs(tm) (intrastromal corneal ring segements).