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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.
 
DevicePOLYCON CONTACT LENS
Generic NameLens, contact (polymethylmethacrylate)
ApplicantWesley Jessen Corp.
333 E. Howard Ave.
Des Plaines, IL 60018
PMA NumberN18120
Supplement NumberS023
Date Received07/24/1989
Decision Date01/23/1990
Product Code HPX 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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