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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 NameWAVESCAN WAVEFRONT SYSTEM SOFTWARE VERSION 3.68
Classification Nameexcimer laser system
Generic Nameexcimer laser for ophthalmic use
ApplicantAMO MANUFACTURING USA, LLC
PMA NumberP930016
Supplement NumberS034
Date Received09/20/2010
Decision Date03/04/2011
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for wavescan wave- front software version 3. 68.
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