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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.
 
DeviceBAUSCH& LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM
Generic NameExcimer laser system
ApplicantTechnolas Perfect Vision GmbH
Messerschmittstr. 1+ 3
München 80992
PMA NumberP990027
Supplement NumberS009
Date Received12/19/2006
Decision Date02/01/2008
Product Code LZS 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE EXPANSION OF THE PHYSICIAN ADJUSTMENT RANGE FOR THE SPHERICAL COMPONENT ROM +2.5 D TO -1.0 D.
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