|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||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Elimination of finished product intravitreal testing for perfluoron and revision of the "purified perfluoro-n-octane analytical test monograph" regarding calculation of impurities. The specification of >=99. 9% for purified perfluoro-n-octane remains unchanged.