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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.
 
DeviceSOFTACT II (POLYMACON)
Generic NameLenses, soft contact, daily wear
Regulation Number886.5925
ApplicantPremier Contact Lens
201 Fourth Ave. N.
Nashville, TN 37219
PMA NumberP830006
Supplement NumberS006
Date Received02/18/1992
Decision Date04/15/1992
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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