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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameTECNIS TORIC 1-PIECE INTRAOCULAR LENS (IOL), TENCNIS TORIC 1-PIECE INTRAOCULAR LENS (IOL), TECNIS TORIC 1-PIECE INTRAOCU
Classification Namelens, intraocular, toric optics
Regulation Number886.3600
ApplicantABBOTT MEDICAL OPTICS INC
PMA NumberP980040
Supplement NumberS058
Date Received02/03/2015
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 - component
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.
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