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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
50 technology drive
irvine, CA 92618
PMA NumberP910061
Supplement NumberS013
Date Received03/30/2006
Decision Date07/20/2006
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling changes for the advanced optics violet-shield model li61aov intraocular lens. The device, as modified, will be marketed under the trade name advanced optics violet-shield model li61aov intraocular lens and is indicated to be used for primary implantation for the correction of aphakia in adult patients where a cataractous lens has been removed by extracapsular cataract extraction methods. The lens is intended for placement in the ciliary sulcus or capsular bag.