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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 Dr.
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
Predetermined Change Control Plan AuthorizedNo
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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