|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|| process change: packaging|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a modified stability protocol, a change in the packaging to an alternate aluminum seal with a flip-off cap, and the addition of a pre-processing modification to siliconize the stoppers used in the filling, stopping, and sealing of perfluoron.