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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 ONE-PIECE SOFT ACRYLIC INTRAOCULAR (IOL) MODEL ZCB00 & TECNIS MULTIFOCAL ONE-PIECE IOL MODEL ZMB00
Classification Nameintraocular lens
Generic Name intraocular lens
Regulation Number886.3600
ApplicantABBOTT MEDICAL OPTICS INC
PMA NumberP980040
Supplement NumberS034
Date Received06/10/2010
Decision Date07/08/2010
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 
Addition of a cosmetic inspection step to the manufacturing process of one-piece intraocular lenses.
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