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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.
 
DeviceNDS LENS MAINTENANCE SYSTEM
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantCiba Vision Corporation
2910 Amwiler Ct.
Atlanta, GA 30360
PMA NumberP900029
Supplement NumberS001
Date Received06/02/1995
Decision Date08/01/1995
Product Code LPN 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
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 LABELING CHANGES TO ENHANCE THE INSTRUCTIONS TO BETTER COMMUNICATE THE PROPER LENS STORAGE TIMEFRAMES WHEN USING THE QUICK CARE SYSTEM.
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