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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.
Generic Nameexcimer laser system
ApplicantAlcon Laboratories, Inc.
2501 discovery drive,suite 500
orlando, FL 32826-3714
PMA NumberP930034
Supplement NumberS009
Date Received04/02/1997
Decision Date03/11/1998
Withdrawal Date 05/18/2010
Product Code LZS 
Docket Number 98M-0329
Notice Date 05/27/1998
Advisory Committee Ophthalmic
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the SVS Apex Plus Excimer Laser Workstation and emphasis(R) disc. These devices are indicated to perform myopic astigmatic photorefractive keratectomy (Toric PRK): 1) for the reduction or elimination of mild to moderate myopia (-1.00 to < -6.00 D) and concomitant reduction or elimination of mild to moderate astigmatism (-1.00 to < -4.00D), in which the combined attempted correction must be < -6.00D spherical equivalent at the spectacle plane; 2) in patients with documentation of a stable manifest refraction(+- 1D) over the past year; and, 3) in patients who are 21 years of age or older.