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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 Sphere, Biofinity Toric, Biofinity Multifocal, Biofinity Energys, Biofinity Sphere XR
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantCooperVision, Inc.
6101 Bollinger Canyon Rd.
Suite 500
San Ramon, CA 94583
PMA NumberP080011
Supplement NumberS156
Date Received07/26/2023
Decision Date08/21/2023
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  
Introduction of a new Programmable Logic Controller (PLC) code version on the labeling and packaging MPac Syncro line 3 (LP3) at the CooperVision Manufacturing, Ltd., Mountpark to produce Biofinity family of lenses.
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