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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.
 
DeviceSVS APEX PLUS EXCIMER LASER WORKSTATION
Classification Nameexcimer laser system
Generic Nameexcimer laser system
Applicant
SUMMIT TECHNOLOGY, INC.
21 hickory dr.
waltham, MA 02154
PMA NumberP910067
Supplement NumberS002
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 change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new laser calibration medium and procedure.
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