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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 NameBIOFINITY (COMFILCON A) SOFT CONTACT LENS
Classification Namelenses, soft contact, extended wear
Regulation Number886.5925
ApplicantCOOPERVISION, INC.
PMA NumberP080011
Supplement NumberS001
Date Received02/27/2009
Decision Date03/25/2009
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of two alternate qualified suppliers of a raw material used in the manufacturing of comfilcon a lenses.
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