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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 NameARRAY MULTIFOCAL IOLS & REZOOM MULTIFOCAL IOLS
Classification Namelens, multifocal intraocular
Regulation Number886.3600
ApplicantADVANCED MEDICAL OPTICS, INC.
PMA NumberP960028
Supplement NumberS024
Date Received09/24/2007
Decision Date10/24/2007
Product Code
MFK[ Registered Establishments with MFK ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Increase in the frequency of microbiological monitoring for the water system in the advanced medical optics (amo) anasco, puerto rico facility.
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