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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.
 
DeviceTECHNOLAS PERFECT VISION 217Z ZYOPTIX SYSTEM
Classification Nameexcimer laser system
Generic Nameexcimer laser system
Applicant
TECHNOLAS PERFECT VISION GMBH
messerschmittstr 1 + 3
munchen 80992
PMA NumberP990027
Supplement NumberS018
Date Received05/01/2012
Decision Date05/17/2013
Product Code
LZS[ Registered Establishments with LZS ]
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 THE ADDITION OF THE ADVANCED PLANOSCAN SOFTWARE TO BE USED WITH THE DEVICE.
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