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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.
 
DeviceBIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantCooperVision, Inc.
6101 Bollinger Canyon Rd.
Suite 500
San Ramon, CA 94583
PMA NumberP080011
Supplement NumberS011
Date Received03/30/2012
Decision Date05/11/2012
Product Code LPM 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
REVALIDATION OF BIOFINITY MANUFACTURING LINE #4 WITH THE FOLLOWING MANUFACTURING CHANGES: 1) AN INCREASE IN TEMPERATURE OF THE BARREL HEATER ON THE INJECTION MOLDING MACHINE; AND 2) A CONSOLIDATION CHANGE IN THE DESIGN OF THE FILL AND CLOSE MODULE.
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