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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.
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
1700 e. st. andrew place
santa ana, CA 92705
PMA NumberP980040
Supplement NumberS041
Date Received09/04/2012
Decision Date08/21/2013
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the packaging configuration/ delivery system for the tecnis® 1-piece intraocular lens (iol), model zcb00. The new packaging configuration will function as both the primary packaging for the lens and as a sterile, disposable insertion system for delivering the lens into the eye. The tecnis® 1-piece iol (model zcb00) in the new packaging configuration/ delivery system is designated the tecnis itec preloaded delivery system, model pcb00, and is indicated for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.