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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 NumberS015
Date Received01/30/2012
Decision Date03/30/2012
Product Code
LWL[ Registered Establishments with LWL ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for minor labeling changes to the approved secondary label lid and to implement an alternate secondary printing operation associated with the implementation of these minor labeling changes.
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