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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.
Generic NameExcimer laser system
ApplicantAMO Manufacturing USA, LLC
510 Cottonwood Drive
Milpitas, CA 95035
PMA NumberP930016
Supplement NumberS007
Date Received03/05/1998
Decision Date11/02/1998
Product Code LZS 
Docket Number 00M-1391
Notice Date 07/14/2000
Advisory Committee Ophthalmic
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the VISX Excimer Laser System. This device is indicated for hyperopic PRK using an ablation zone with a correction diameter of 5.0 mm and an overall diameter of 9.0mm.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness