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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 HSM UV LIGHT ABSORBING PMMA ANTERIOR CHAMBER IOLS
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantABBOTT MEDICAL OPTICS INC
PMA NumberP880070
Supplement NumberS012
Date Received04/12/2007
Decision Date05/08/2007
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of a second eto sterilizer (gee 6913 ar-1) used in the sterilization of iols manufactured at the amo groningen, netherlands facility.
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