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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.
 
DeviceTECNIS ITEC PRELOADED DELIVERY SYSTEM
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
Applicant
ABBOTT MEDICAL OPTICS INC
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.
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