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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.
 
DeviceCEEON ULTRAVIOLET LIGHT-ABSORBING POLYMETHYLMETHACRYLATE (PMMA) POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS)
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantAdvanced Medical Optics, Inc.
1700 E. St. Andrew Pl.
P.O. Box 25162
Santa Ana, CA 92705
PMA NumberP810055
Supplement NumberS072
Date Received05/29/2008
Decision Date07/02/2008
Withdrawal Date04/15/2009
Product Code HQL 
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  
IMPLEMENTATION OF THE MEASURING IOL QUALITY SYSTEM FOR DETERMINING OPTICAL PERFORMANCE OF IOLS MANUFACTURED AT THE FACILITY.
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