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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 NumberS003
Date Received08/26/1996
Decision Date04/24/1997
Product Code LZS 
Docket Number 97M-0084
Notice Date 04/17/1998
Advisory Committee Ophthalmic
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? Yes
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE VISX EXCIMER LASER SYSTEM (MODELS B & C). THIS DEVICE IS INDICATED FOR MYOPIC ASTIGMATIC PHOTOREFRACTIVE KERATECTOMY (PRKA) USING AN ABLATION ZONE WITH A 6.0 MM MAJOR AXIS
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