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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceCEEON ULTRAVIOLET LIGHT-ABSORBING POLYMETHYLMETHACRYLATE (PMMA) POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS)
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
Applicant
ADVANCED MEDICAL OPTICS, INC.
1700 e. st. andrew place
p.o. box 25162
santa ana, CA 92705-4933
PMA NumberP810055
Supplement NumberS072
Date Received05/29/2008
Decision Date07/02/2008
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Implementation of the measuring iol quality system for determining optical performance of iols manufactured at the facility.
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