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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 PLUS Extended Range of Vision Intraocular Lens (IOL), Model ZHR00, TECNIS Symfony PLUS Extended Range of
Generic NameExtended depth of focus intraocular lens
Regulation Number886.3600
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP980040
Supplement NumberS109
Date Received11/06/2019
Decision Date05/01/2020
Product Code POE 
Advisory Committee Ophthalmic
Clinical TrialsNCT03500198
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the modification of the optics to elongate the depth of focus further than the optical parent lens, the TECNIS Symfony Extended Range of Vision IOL, Model ZXR00.
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