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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 Symfony™ Extended Range Of Vision Intraocular Lens
Generic NameExtended depth of focus intraocular lens
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP980040
Supplement NumberS161
Date Received07/03/2023
Decision Date12/22/2023
Product Codes HQL POE 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval of modifications to the final professional and patient labeling for the TECNIS Symfony™ Extended Range Of Vision Intraocular Lens (Models ZXR00 and ZXT 150-600) to include the results of your postmarket study.
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