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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-FORM 55EW; LL-55; SOFTCON EW2
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantUnilens Corp., USA
21 N Park Pl. Blvd.
Clearwater, FL 33759
PMA NumberP890040
Supplement NumberS008
Date Received02/04/2016
Decision Date02/29/2016
Product Code LPM 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Increase to the sterilization load size to utilize more of the chamber capacity.
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