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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.
 
Devicetetrafilcon A Soft (Hydrophilic) Extended Wear Contact Lenses
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantCooperVision, Inc.
6150 Stoneridge Mall Rd.
Suite 370
Pleasanton, CA 94588
PMA NumberN17679
Supplement NumberS040
Date Received06/07/2018
Decision Date06/29/2018
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  
Replacement of the paper system used for managing the preparation and documentation of the solution records at the CooperVision, Inc. Scottsville, NY manufacturing facility with a computer based system.
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