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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceTECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS
Generic NameLens, multifocal intraocular
Regulation Number886.3600
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Drive
Suite 200
Irvine, CA 92618
PMA NumberP080010
Supplement NumberS001
Date Received01/27/2009
Decision Date06/12/2009
Product Code MFK 
Advisory Committee Ophthalmic
Clinical TrialsNCT00747565
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Combination ProductNo
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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