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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 NumberS022
Date Received05/27/1988
Decision Date12/21/1988
Product Code HPX 
Docket Number 89M-0002
Notice Date 03/07/1989
Advisory Committee Ophthalmic
Supplement TypePanel 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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