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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameTECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)
Classification Namelens, multifocal intraocular
Regulation Number886.3600
ApplicantABBOTT MEDICAL OPTICS INC
PMA NumberP080010
Date Received04/02/2008
Decision Date01/16/2009
Product Code
MFK[ Registered Establishments with MFK ]
Docket Number 09M-0034
Notice Date 01/27/2009
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the tecnis multifocal foldable posterior chamber intraocular lenses (iols), models zm900 and zma00. The devices are indicated for primary implantation for the visual correction of aphakia adult patients with and without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire near, intermediate, and distance vision with increased spectacle independence.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S007 S008 S009 S010 
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