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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 NameVISX EXCIMER LASER SYSTEM MODELS B AND C FOR PHOTOREFRACTIVE KERATECTOMY (PRK)
Classification Nameexcimer laser system
Generic Nameexcimer laser for ophthalmic use
ApplicantVISX, INCORPORATED
PMA NumberP930016
Supplement NumberS008
Date Received09/15/1998
Decision Date02/23/1999
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to consider report of the postapproval studies a final report and to discontinue all prk postapproval study requirements. The model c(star) device, as modified in supplement 7, will be marketed under the trade name visx star s2 excimer laser system and is indicated for the treatment of myopia, astigmatism and hyperopia (sphere only).
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