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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 Toric Extended Range of Vision IOL and TECNIS Toric 1-Piece IOL
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP980040
Supplement NumberS091
Date Received05/15/2018
Decision Date06/11/2018
Product Code HQL 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Manufacture the TECNIS® Toric 1-Piece IOL, Models ZCT150, ZCT225, ZCT300, ZCT375, ZCT400, ZCT450, ZCT525 and ZCT600, and the TECNIS® Symfony Toric Extended Range of Vision IOLs, Models ZXT150, ZXT225, ZXT300 and ZXT375, at Johnson & Johnson Surgical Vision, Inc.’s (J&J Vision) AMO Puerto Rico Manufacturing, Inc. facility in Añasco, Puerto Rico.
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