|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.|
|Classification Name||fluid, intraocular|
|Generic Name||liquid ultrapure perfluoro-n-octane (pfno)|
|Supplement Type||normal 180 day track|
|Supplement Reason|| location change: sterilizer|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the filter sterilization and aseptic fill facility located at chesapeake biological laboratories (cbl), ind. , baltimore, maryland 21230.