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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.
 
DeviceAOSEPT DISINFECTANT
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantCiba Vision Care
11460 Johns Creek Pkwy.
Duluth, GA 30136
PMA NumberP820040
Supplement NumberS033
Date Received07/27/1995
Decision Date12/13/1995
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 MODIFICATIONS IN THE PACKAGE INSERT
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