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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 (FORMERLY OMNIMED) EXCIMER LASER SYSTEM FOR PHOTOREFRACTIVE KERATECTOMY (PRK)
Classification Nameexcimer laser system
ApplicantSUMMIT TECHNOLOGY, INC.
PMA NumberP930034
Supplement NumberS001
Date Received12/26/1995
Decision Date02/05/1997
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Type Special Supplement
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to use laser vision correction or lvc as a synonym for photorefractive keratectomy or prk in your labeling. The application is approved subject to the condition that lvc will not be used in the following instances: 1)in ads to practitioners; 2)in section that contain the approved indication, contraindication, warning, precaution, caution, and "a-j" statements in the fda approval order dated october 20, 1995; 3) on the title page of the patient information booklet; 4) at the beginning of text in a booklet or an ad, until the term "laser vision correction (lvc)" is defined as a replacement for prk; and 5) when distinguishing the various surgeries, e. G. , ptk and prk (not lvc).
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