|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|| design change - minor|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for adding blister packaging to the vial product that is then subjected to a steam sterilization process in order to provide a finished product vial with a sterile exterior. Also, approval of a 10 ml vial for the 7 ml fill product to allow sterilization headspace.