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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.
 
DeviceDURASOFT CONTACT LENS
Generic NameLenses, soft contact, daily wear
Regulation Number886.5925
ApplicantWesley Jessen Corp.
400 W. Superior St.
Chicago, IL 60610
PMA NumberN17852
Supplement NumberS021
Date Received07/08/1987
Decision Date10/07/1987
Product Code LPL 
Advisory Committee Ophthalmic
Supplement Type 30-Day Supplement
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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