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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSVS APEX PLUS EXCIMER LASER WORKSTATION
Generic NameExcimer laser system
ApplicantALCON RESEARCH, LTD. DBA ALCON LABORATORIES, INC.
6201 SOUTH FREEWAY
FORT WORTH, TX 76134
PMA NumberP910067
Supplement NumberS002
Date Received11/20/1996
Decision Date03/12/1997
Withdrawal Date 05/18/2010
Product Code LZS 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A NEW LASER CALIBRATION MEDIUM AND PROCEDURE.
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