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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 NameMULTIFOCAL SILICONE & MULTIFOCAL ACRYLIC POSTERIOR CHAMBER INTRAOCULAR LENSES
Classification Namelens, multifocal intraocular
Regulation Number886.3600
ApplicantADVANCED MEDICAL OPTICS, INC.
PMA NumberP960028
Supplement NumberS025
Date Received10/24/2007
Decision Date11/19/2007
Product Code
MFK[ Registered Establishments with MFK ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Use of an additional sterilization chamber for ethylene oxide (eo) sterilization of iol?s resulting in better temperature distribution, better space utilization, and lower sterilization costs than the current chamber.
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