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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.
Classification Nameexcimer laser system
Generic Nameexcimer laser system
AMO Manufacturing USA, LLC
510 cottonwood drive
milpitas, CA 95035
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 report
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.