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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.
 
Trade NameSVS APEX PLUS EXCIMER LASER WORKSTATION AND EMPHASIS DISC
Classification Nameexcimer laser system
ApplicantSUMMIT TECHNOLOGY, INC.
PMA NumberP930034
Supplement NumberS009
Date Received04/02/1997
Decision Date03/11/1998
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 98M-0329
Notice Date 05/27/1998
Advisory Committee Ophthalmic
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
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.
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