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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 SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES
Classification Nameintraocular lens
Generic Nameuv absorbing iol
Regulation Number886.3600
ApplicantADVANCED MEDICAL OPTICS, INC.
PMA NumberP940007
Supplement NumberS006
Date Received09/05/2000
Decision Date04/02/2001
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for sterilizing the silicone posterior chamber intraocular lens, model 912, at the facility in groningen, the netherland and for changes in the sterilization cycle parameters for model 912 from 100% ethylene oxide (et0) to 20 % et0/80% carbon dioxide.
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