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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
Trade NamePERFLUORON
Classification Namefluid, intraocular
Generic Nameliquid ultrapure perfluoro-n-octane (pfno)
Regulation Number886.4275
ApplicantALCON LABORATORIES
PMA NumberP950018
Supplement NumberS007
Date Received07/13/2001
Decision Date08/07/2001
Product Code
LWL[ Registered Establishments with LWL ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product 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.
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