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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 MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS
Classification Namelens, multifocal intraocular
Regulation Number886.3600
ApplicantABBOTT MEDICAL OPTICS INC
PMA NumberP080010
Supplement NumberS001
Date Received01/27/2009
Decision Date06/12/2009
Product Code
MFK[ Registered Establishments with MFK ]
Advisory Committee Ophthalmic
Clinical Trials NCT00747565
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the labeling for the tecnis multifocal foldable posterior chamber intraocular lens (iol), models zm900 and zma00, revision the directions for use (dfu) and the patient brochure for the lens models with updated one-year follow up data from the clinical investigation for the lenses.
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