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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 2 MODEL SA44 MULTIFOCAL INTRAOCULAR LENS (IOL)
Classification Namelens, multifocal intraocular
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantADVANCED MEDICAL OPTICS, INC.
PMA NumberP960028
Supplement NumberS009
Date Received06/04/2003
Decision Date08/29/2003
Product Code
MFK[ Registered Establishments with MFK ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for extending the power range of the array 2 model sa44 multifocal iol up to 35 diopters.
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