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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
Generic NameExcimer laser system
ApplicantAMO Manufacturing USA, LLC
510 Cottonwood Drive
Milpitas, CA 95035
PMA NumberP930016
Supplement NumberS004
Date Received12/17/1996
Decision Date06/12/1997
Product Code LZS 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Other
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR REVISED PROTOCOL FOR POST-APPROVAL STUDY TO DETECT AND REPORT RARE BUT SERIOUS ADVERSE EVENT. *PLEASE NOTE THAT LONG-TERM DATA MUST BE REFLECTED IN THE LABELING (VIA A SUPPLEMENT TO THE PMA) WHEN THE ADDITIONAL FOLLOW-UPS AND/OR POST-APPROVAL STUDIES ARE COMPLETED.
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