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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 ACRYLIC IOLS
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
Applicant
ABBOTT MEDICAL OPTICS INC
1700 e. st. andrew place
santa ana, CA 92705
PMA NumberP990080
Supplement NumberS021
Date Received03/27/2007
Decision Date04/26/2007
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Reduce operator handling of lenses by eliminating the 100% visual inspection processing step conducted at post-tumbling for all of the soft acrylic iols.
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