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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namefluid, intraocular
Generic Nameliquid ultrapure perfluoro-n-octane (pfno)
Regulation Number886.4275
PMA NumberP950018
Date Received04/28/1995
Decision Date02/29/1996
Product Code
LWL[ Registered Establishments with LWL ]
Docket Number 96M-0233
Notice Date 07/18/1996
Advisory Committee Ophthalmic
Expedited Review Granted? Yes
Combination Product No
Approval Order Statement 
Approval for perfluoron (purified perfluoro-n-octane liquid) this device, a perfluorocarbon liquid, is an intraoperative tool.
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S013 S014 S015 S016 S018