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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 1-PEICE LENS MODEL ZCB00; TECNIS MULTIFOCAL 1-PIECE LENS MODEL ZMB00, SENSAR 1-PIECE LENS MODEL AAB00
Classification Nameintraocular lens
Generic Name intraocular lens
Regulation Number886.3600
ApplicantABBOTT MEDICAL OPTICS INC
PMA NumberP980040
Supplement NumberS038
Date Received01/30/2012
Decision Date02/29/2012
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Implement a software and hardware upgrade to the equipment used to measure optical properties of intra- ocular lenses.
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