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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 INTRAOCULAR LENS (IOL), TENCNIS TORIC 1-PIECE INTRAOCULAR LENS (IOL), TECNIS TORIC 1-PIECE INTRAOCU
Classification Namelens, intraocular, toric optics
Generic Namelens, intraocular, toric optics
Regulation Number886.3600
Applicant
Johnson & Johnson Surgical Vision, Inc.
1700 e. st. andrew place
santa ana, CA 92705
PMA NumberP980040
Supplement NumberS058
Date Received02/02/2015
Decision Date07/31/2015
Product Code
MJP[ Registered Establishments with MJP ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR TECNIS® TORIC 1-PIECE ACRYLIC IOLS, MODELS ZCT450, ZCT525 AND ZCT600, AND THE TECNIS® TORIC CALCULATOR.
Post-Approval StudyShow Report Schedule and Study Progress
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