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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 INTRAOCULAR LENS, MODEL ZCB00
Classification Nameintraocular lens
Generic Name intraocular lens
Regulation Number886.3600
ApplicantADVANCED MEDICAL OPTICS, INC.
PMA NumberP980040
Supplement NumberS023
Date Received03/21/2008
Decision Date05/27/2008
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for revisions to the labeling for the tecnis one-piece intraocular lens, model zcb00 as follows: 1) modifications to the device description section to include an additional description of wavefront-designed aspheric optic, squared posterior optic edge, frosted optic edge, an optical image quality graph for the aspheric optic; 2) modifications to the adverse events sand the clinical trial sections to reflect data from the one-year clinical study results; and 3) other administrative changes such as the rewording of the last sentence on page 1, adding trademarks to the detailed device description section and revision the numbering of the figures.
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