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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
ABBOTT MEDICAL OPTICS 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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