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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.
 
DeviceVistakon (Senofilcon A) Brand contact lenses
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantVistakon, Division of Johnson & Johnson Vision Car
7500 Centurion Pkwy.
Suite 100 - Erca
Jacksonville, FL 32256
PMA NumberP040045
Supplement NumberS080
Date Received08/01/2017
Decision Date08/30/2017
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  
Change to the raw material specification of a visibility tint used in the VISTAKON® (senofilcon A) and (etafilcon A) Brand Contact Lenses.
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