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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 NameTECHNOLAS 217Z ZYOPTIX SYSTEM
Classification Nameexcimer laser system
Generic Nameexcimer laser system
ApplicantTECHNOLAS GMBH PERFECT VISION
PMA NumberP990027
Supplement NumberS016
Date Received09/17/2010
Decision Date01/26/2011
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
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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