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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"
Classification Nameexcimer laser system
Generic Nameeximer laser for ophthalmic use
ApplicantVISX, INCORPORATED
PMA NumberP930016
Supplement NumberS002
Date Received05/16/1996
Decision Date11/07/1996
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for: 1)a protocol for a prospective postapproval study to detect rare but serious adverse events; and, 2)changes to update your phase iii prk protocol for postapproval follow-up purposes. Fda acknowledges that supplement 1 (approved on 15-oct-96) negates the need for a contrast sensitivity/glare study or protocol. Please note that long-term data must be reflected in the labeling (via a supplement to the pma) when the add'l follow-ups and/or postapproval studies are completed.
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