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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 (etafilcon A) Brand Contact Lenses
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantVistakon, Johnson & Johnson Vision Products, Inc.
7500 Centurion Pkwy.
Jacksonville, FL 32256
PMA NumberN18033
Supplement NumberS099
Date Received06/18/2018
Decision Date07/10/2018
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  
Modification of the heat seal mechanism used to seal the foil lidstock onto the primary package during the manufacturing process of VISTAKON® (etafilcon A) Brand Contact Lenses.
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