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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 Laboratories, Inc.
2501 Discovery Dr.,
Suite 500
Orlando, FL 32826
PMA NumberP930034
Supplement NumberS011
Date Received05/21/1998
Decision Date06/04/1998
Withdrawal Date05/18/2010
Product Code LZS 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for an external chiller option for the SVS Apex Plus Excimer Lasery System.
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