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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.
 
DeviceSOFT CONTACT LENS
Generic NameLenses, soft contact, daily wear
Regulation Number886.5925
ApplicantCiba Vision Corporation
11460 Johns Creek Pkwy.
Duluth, GA 30097
PMA NumberN17987
Supplement NumberS021
Date Received08/23/1989
Decision Date09/18/1989
Withdrawal Date06/05/2013
Product Code LPL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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