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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 APEX EXIMER LASER WORKSTATION
Generic NameExcimer laser system
ApplicantAlcon Laboratories, Inc.
2501 Discovery Dr.,
Suite 500
Orlando, FL 32826
PMA NumberP930034
Supplement NumberS007
Date Received11/20/1996
Decision Date03/12/1997
Withdrawal Date05/18/2010
Product Code LZS 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A NEW LASER CALIBRATION MEDIUM AND PROCEDURE.
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