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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 WITH THE EMPHASIS DISCS
Classification Nameexcimer laser system
Generic Nameexcimer laser system
Applicant
Alcon Laboratories, Inc.
2501 discovery drive,suite 500
orlando, FL 32826-3714
PMA NumberP930034
Supplement NumberS012
Date Received07/14/1998
Decision Date10/21/1999
Product Code
LZS[ Registered Establishments with 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 Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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