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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 NumberS006
Date Received06/24/1996
Decision Date10/22/1996
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for discontinuing further follow-up and report of the <6. 0 mm subjects in accordance with the post approval requirements.
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