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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 (PURIFIED PERFLUORO-N-OCTANE LIQUID)
Classification Namefluid, intraocular
Generic Nameliquid ultrapure perfluoro-n-octane (pfno)
Regulation Number886.4275
ApplicantALCON LABORATORIES
PMA NumberP950018
Supplement NumberS001
Date Received10/17/1996
Decision Date12/11/1996
Product Code
LWL[ Registered Establishments with LWL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification of the stability protocol to increase the acceptance criteria limit for uv/vis absorbance on accelerated agin (45 degrees c) samples from <0. 2 to <0. 4 absorbance units cm-1 at 220nm.
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