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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 CONTACTS 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 NumberS001
Date Received06/25/1998
Decision Date07/09/1998
Withdrawal Date 05/12/2014
Product Code LPM 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Requested that the device which is terminally sterilized by steam sterilization, be released into distribution using parametric criteria rather than the existing Biological Indicators.
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