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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.
 
DeviceUNIZYME(TM) ENZYMATIC CLEANER
Generic NameAccessories, solution, ultrasonic cleaners for lenses
Regulation Number886.5928
ApplicantCiba Vision Corporation
11460 Johns Creek Pkwy.
Duluth, GA 30097
PMA NumberP960024
Supplement NumberS001
Date Received04/15/1997
Decision Date07/03/1997
Product Code LYL 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for addition of Ciba Vision's SOLOCare(TM) Brand Multi-Purpose Solution to the labeling of the Unizyme(TM) Enzymatic Cleaner as a diluent to be used sequentially with the Unizyme(TM) enzyme.
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