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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-55 EW APHAKIC (VIFILCON A) SOFT(HYDROPHILIC) SPHERICAL CONTACT LENS FOR EXTENDED WEAR
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantUNILENS CORPORATION USA
10431 72nd Street North
Largo, FL 33777
PMA NumberP960039
Supplement NumberS002
Date Received01/29/2001
Decision Date01/03/2002
Withdrawal Date 05/12/2014
Product Code LPM 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE MANUFACTURING FACILITY LOCATED AT UNILENS CORPORATION, USA, LARGO, FLORIDA.
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