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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 NameSVS APEX APEX EXIMER LASER WORKSTATION
Classification Nameexcimer laser system
ApplicantSUMMIT TECHNOLOGY, INC.
PMA NumberP930034
Supplement NumberS007
Date Received11/20/1996
Decision Date03/12/1997
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new laser calibration medium and procedure.
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