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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 OPTIBLUE INTRAOCULAR LENS (IOL) MODEL ZV9003 & 1-PIECE IOL MODEL ZCB00V
Classification Nameintraocular lens
Generic Name intraocular lens
Regulation Number886.3600
ApplicantABBOTT MEDICAL OPTICS INC
PMA NumberP980040
Supplement NumberS035
Date Received10/18/2010
Decision Date09/12/2012
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Clinical Trials NCT00747227
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of two additives (i. E. , 2-(3-t-butyl-2-hydroxy-5-vinyl-phenyl)-5-chlorobenzotriazole) (uvam) and yellow dye) to the sensar soft acrylic iols (models za9003 and zcb00).
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