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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 NameBIOFINILITY (COMFILCON A) SOFT (HYDROPHYLIC) EXTENDED-WEAR CONTACT LENSES
Classification Namelenses, soft contact, extended wear
Regulation Number886.5925
ApplicantCOOPERVISION, INC.
PMA NumberP080011
Supplement NumberS016
Date Received06/25/2012
Decision Date07/17/2012
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Requalification of manufacturing equipment.
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