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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 NameAARIS AND AARIS WITH ADAPTIV OPTICS INTRAOCULAR LENS
Classification Nameintraocular lens
Regulation Number886.3600
ApplicantAAREN SCIENTIFIC INC
PMA NumberP100016
Supplement NumberS001
Date Received02/19/2013
Decision Date05/28/2013
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to the trade name of the approved lenses and labeling changes to the unit carton, including a change to the color scheme and format. The device, as modified, will be marketed under the trade name aaris acrylic intraocular lens (iol), models ec-3 and ec-3 precision aspheric lens (pal) and is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed.
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