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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 POSTERIOR CHAMBER INTRAOCULAR LENS
Classification Namelens, multifocal intraocular
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantADVANCED MEDICAL OPTICS, INC.
PMA NumberP960028
Supplement NumberS013
Date Received07/05/2005
Decision Date12/21/2005
Product Code
MFK[ Registered Establishments with MFK ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modification of the indication statement with standardized language for the models of the array family of multifocal intraocular lenses (models sa40n, sa40n2, sa40e, aa40e, aa50 and nxg1). The devices, as modified, will be marketed under the trade name array and are indicated for: the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed and who desire near, intermediate, and distance vision without reading add and increased spectacle, independence.
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