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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 WITH THE EMPHASIS DISCS
Generic NameExcimer laser system
ApplicantAlcon Laboratories, Inc.
2501 Discovery Dr.,
Suite 500
Orlando, FL 32826-3714
PMA NumberP930034
Supplement NumberS012
Date Received07/14/1998
Decision Date10/21/1999
Withdrawal Date05/18/2010
Product Code LZS 
Docket Number 00M-0424
Advisory Committee Ophthalmic
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the SVS Apex Plus Excimer Laser Workstation, emphasis(R) discs K and L, and axicon. These devices are indicated to perform hyperopic PRK.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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