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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.
 
DeviceSOFTICS(TM) (POLYMACON)
Generic NameLenses, soft contact, daily wear
Regulation Number886.5925
ApplicantIdeal Optics, Inc.
4000 Cumberland Pkwy.
Bldg. 500
Atlanta, GA 30339
PMA NumberP830012
Supplement NumberS004
Date Received11/02/1989
Decision Date06/25/1990
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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