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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(R)217A OPHTHALMIC EXCIMER LASER SYSTEM
Generic NameExcimer laser system
ApplicantTechnolas Perfect Vision GmbH
Messerschmittstr. 1+ 3
München 80992
PMA NumberP990027
Supplement NumberS003
Date Received04/27/2001
Decision Date09/25/2001
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 TO ADD AN ACTIVE EYETRACKER AS AN ACCESSORY TO THE LASER SYSTEM.
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