|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||ZIRCONIA SILICATE BEAD IOL TUMBLE POLISHING|
|Classification Name||intraocular lens|
|Supplement Type||normal 180 day track|
|Supplement Reason|| location change - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the reduction in biological indicator incubation time from 7 to 5 days.