|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||NCRYSOF (R) UV ABSORBING INTRAOCULAR LENSES|
|Classification Name||intraocular lens|
|Supplement Type||normal 180 day track|
|Supplement Reason|| process change: sterilization|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Alternate sterilization process including aeration and th4e establishment of the biological indicator incubation time at your huntington, west virginia site.