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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 NameSOFT ACRYLIC MULTIFOCAL ARRAY 2 (MODELS AA40E AND AA50) AND REZOOM (MODEL NXG1) INTRAOCULAR LENSES
Classification Namelens, multifocal intraocular
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantADVANCED MEDICAL OPTICS, INC.
PMA NumberP960028
Supplement NumberS011
Date Received10/04/2004
Decision Date03/23/2005
Product Code
MFK[ Registered Establishments with MFK ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for soft acrylic multifocal array 2 (models aa40e and aa50) and rezoom (model nxg1) intraocular lenses.
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