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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 NameTECNIS MULTIFOCAL 1-PIECE INTRAOCULAR LENS WITH TECNIS ITEC PRELOADED DELIVERY SYSTEM
Classification Nameintraocular lens
Generic Name intraocular lens
Regulation Number886.3600
ApplicantABBOTT MEDICAL OPTICS INC
PMA NumberP980040
Supplement NumberS046
Date Received10/22/2013
Decision Date04/28/2014
Product Code
HQL[ Registered Establishments with HQL ]
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 a change in the packaging/delivery system for the tecnis® multifocal 1-piece intraocular lens, model zmb00. The tecnis® multifocal 1-piece intraocular lens in the new packaging/ delivery system is designated the tecnis itec preloaded delivery system, model pmb00, and is indicated for primary implantation for the visual correction of aphakia in 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. The intraocular lens is intended to be placed in the capsular bag.
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