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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 NameCEEON MODEL 912 FOLDABLE INTRAOCULAR LENS
Classification Nameintraocular lens
Generic Nameuv absorbing iol
Regulation Number886.3600
ApplicantPHARMACIA & UPJOHN CO.
PMA NumberP940007
Supplement NumberS005
Date Received07/01/1999
Decision Date07/30/1999
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the warning section of the lens package insert. Specifically: "when implanting a lens with a smaller optic (less than or equal to 5. 5mm), it is recommended that capsulorhexis, with a diameter smaller than the lens optic, be performed. A thorough cortical cleaning before lens insertion is also recommended. ".
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