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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceVISX EXCIMER LASER SYSTEM MODELS B AND C
Classification Nameexcimer laser system
Generic Nameexcimer laser system
Applicant
AMO Manufacturing USA, LLC
510 cottonwood drive
milpitas, CA 95035
PMA NumberP930016
Supplement NumberS001
Date Received04/18/1996
Decision Date10/15/1996
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
LABELING CHANGES (I.E., MINOR EDITORAL CHANGES TO THE PATIENT INFORMATION BOOKLET, CONTRAST SENSITIVITY/GLARE PRECAUTIONARY STATEMENT IN LIEU OF A POSTAPPROVAL CONTRAST SENSITIVITY STUDY, AND DEFINITIONS OF POTENTIAL RISKS WITH PRK)
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