|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||real-time process|
|Supplement Reason|| process change - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a new stability protocol that will extend the expiration dating for perfluoron from 2 years to up to 4 years for the currently approved product configuration, with stability testing data reported via annual reports in the future.