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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 NameLASERVISION/VISX EXCIMER LASER FOR PRK AND PTK (MOBILEXCIMER)
Classification Nameexcimer laser system
ApplicantLASER VISION CENTERS, INC.
PMA NumberP960019
Supplement NumberS002
Date Received04/17/1998
Decision Date05/05/1998
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for two add'l indications, myopic astigmatic prk (prka) and high myopia with and without astigmatism for the device. The device, as modified, will be marketed under the trade name mobilexcimer(r) for ptk and prk. The mobilexcimer(r) for ptk and prk remains indicated for the indications listed in fda's letter of 4/27/97 (p960019/s001 and the new indications contained in this supplement.
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