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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCOOPERVISION BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantCooperVision, Inc.
6101 Bollinger Canyon Road, Suite 500
San Ramon, CA 94583
PMA NumberP080011
Supplement NumberS013
Date Received06/05/2012
Decision Date07/03/2012
Product Code LPM 
Advisory Committee Ophthalmic
Clinical TrialsNCT00597467
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
INSTALLATION OF TWO (UPGRADED INJECTION MOLDING AND CHANGE IN THE DESIGN OF THE PEEL MODULE) ADDITIONAL MANUFACTURING LINES.
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