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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 NameTECNIS ACRYLIC IOL
Classification Nameintraocular lens
Generic Nameposterior chamber intraocular lenses
Regulation Number886.3600
ApplicantABBOTT MEDICAL OPTICS INC
PMA NumberP990080
Supplement NumberS038
Date Received05/24/2013
Decision Date06/18/2013
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
New test method validation for the ultra high performance liquid chromatography (uhplc) system.
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