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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.
 
DeviceCSI (CROFILCON A) EXTENDED WEAR SOFT (HYDROPHILIC) CONTACT LENS
Generic NameLenses, soft contact, daily wear
Regulation Number886.5925
ApplicantCIBA VISION CORPORATION
11460 JOHNS CREEK PARKWAY
DULUTH, GA 30097
PMA NumberN17987
Supplement NumberS026
Date Received07/28/1999
Decision Date08/30/1999
Withdrawal Date 06/05/2013
Product Code LPL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval to transfer manufacturing of the CSI lens to the manufacturing site located at Wesley Jessen, Inc., Route 173, El Jibaro Industrial Park, Cidra, Puerto Rico.
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