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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.
 
Trade NameFOLDABLE ULTAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES(IOLS), CEEON 911A,913A 7 TECNIS Z9000,Z9001
Classification Nameintraocular lens
Generic Nameposterior chamber intraocular lenses
Regulation Number886.3600
ApplicantADVANCED MEDICAL OPTICS, INC.
PMA NumberP990080
Supplement NumberS018
Date Received12/19/2006
Decision Date01/16/2007
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the purification step for one of the components of the silicone raw materials.
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