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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 Nameperfluorocarbon liquid
Regulation Number886.4275
PMA NumberP910068
Supplement NumberS001
Date Received04/26/1999
Decision Date04/04/2001
Product Code
LWL[ Registered Establishments with LWL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for 1) manufacturing site change: the new site for manufacturing the bulk medical grade perfluoroperhydrophenanthrene (apf-215m) will be at fluoromed, l. P. (fmlp), round rock, texas 78664; 2) manufacturing change: apf-215m will be manufactured from perfluoroperhydrophenanthrene raw material instead of from phenanthrene raw material; and 3) apf-215m specification change regarding testing parameter for lower boiling components.