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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
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantCooperVision, Inc.
6101 Bollinger Canyon Road, Suite 500
San Ramon, CA 94583
PMA NumberP080011
Supplement NumberS025
Date Received07/01/2013
Decision Date07/30/2013
Product Code LPM 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
RELOCATION OF BIOFINITY LINE #4 IN THE SAME PRODUCTION AREA AND ALSO A CHANGE IN THE MOLDING MACHINE PLATFORM.
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