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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSOFTCON EW 2 & SOFT-55 EW APHAKIC SOFT CONTACT LENSES
Classification Namelenses, soft contact, extended wear
Regulation Number886.5925
ApplicantUNILENS CORP., USA
PMA NumberP960039
Supplement NumberS003
Date Received01/02/2008
Decision Date03/03/2008
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Type135 review track for 30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to begin parametric release for hydrophilic lenses packaged in vials.
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