|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||ENUCLENE(R) OPHTHALMIC SOLUTION|
|Classification Name||solution, cleaning/lubricating, artifical eye|
|Supplement Type||normal 180 day track|
|Supplement Reason|| location change: manufacturer|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the alternate manufacturing facility located at alcon laboratories, inc. , aspex manufacturing facility, 6201 south freeway, fort worth, tx 76134.