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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.
 
DeviceSOFTCON EW 2 & SOFT-55 EW APHAKIC SOFT CONTACT LENSES
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantUnilens Corporation, USA
10431 72nd St., N.
Largo, FL 33777
PMA NumberP960039
Supplement NumberS003
Date Received12/31/2007
Decision Date03/03/2008
Withdrawal Date05/12/2014
Product Code LPM 
Advisory Committee Ophthalmic
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO BEGIN PARAMETRIC RELEASE FOR HYDROPHILIC LENSES PACKAGED IN VIALS.
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