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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 Toric 1-Piece IOL Model ZCT
Generic NameLENS, INTRAOCULAR, TORIC OPTICS
Regulation Number886.3600
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP980040
Supplement NumberS079
Date Received02/23/2017
Decision Date03/24/2017
Product Code MJP 
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  
Addition of the AMO Kulim, Malaysia manufacturing site for the production of your TECNIS Toric IOL Models ZCT150, ZCT225, ZCT300, ZCT375, ZCT400, ZCT450, ZCT525, and ZCT600.
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