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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 NameCOPPER VISION BIOFINITY (COMFILCON A) SOFT EXTENDED WEAR CONTACT LENSES
Classification Namelenses, soft contact, extended wear
Regulation Number886.5925
ApplicantCOOPERVISION, INC.
PMA NumberP080011
Supplement NumberS012
Date Received05/22/2012
Decision Date06/19/2012
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Relocation and revalidation of a manufacturing line number 3.
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