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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 217Z ZYOPTIX SYSTEM
Generic NameExcimer laser system
ApplicantTECHNOLAS PERFECT VISION GMBH
MESSERSCHMITTSTR 1 + 3
MUNCHEN 80992
PMA NumberP990027
Supplement NumberS016
Date Received09/17/2010
Decision Date01/26/2011
Product Code LZS 
Advisory Committee Ophthalmic
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR 1) A SINGLE PART HARD DISK DRIVE; 2) AN ADDITIONAL CALIBRATION TOOL; 3) CHANGE THE SPUTTER PROCESS OF THE APERTURE; AND 4) PRODUCTION OF THE HIGH PRESSURE UNIT AND ASSOCIATED TESTING OUTSOURCED TO A NEW SUPPLIER.
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