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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.
 
DevicePreference (tetrafilcon A) Soft (hydrophillic) 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 NumberS038
Date Received10/23/2017
Decision Date11/16/2017
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  
Conversion of manufacturing equipment for Preference Sphere (tetrafilcon A) lenses produced at the CooperVision Incorporated manufacturing facility in Scottsville, New York.
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