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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 NameAMO TECNIS ACRYLIC INTRAOCULAR LENS (IOL) MODEL ZA9003
Classification Nameintraocular lens
Generic Nameposterior chamber intraocular lenses
Regulation Number886.3600
ApplicantABBOTT MEDICAL OPTICS INC
PMA NumberP990080
Supplement NumberS036
Date Received11/14/2011
Decision Date04/23/2012
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Type135 review track for 30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the test method used to determine bacterial endotoxin levels of intraocular lenses.
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