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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.
Classification Namefluid, intraocular
Generic Nameliquid ultrapure perfluoro-n-octane (pfno)
Regulation Number886.4275
PMA NumberP950018
Supplement NumberS008
Date Received12/26/2001
Decision Date07/29/2002
Product Code
LWL[ Registered Establishments with LWL ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for adding blister packaging to the vial product that is then subjected to a steam sterilization process in order to provide a finished product vial with a sterile exterior. Also, approval of a 10 ml vial for the 7 ml fill product to allow sterilization headspace.