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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.
 
DeviceINFINITY LS EXCIMER LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameexcimer laser system
Applicant
Alcon Laboratories, Inc.
2501 discovery drive,suite 500
orlando, FL 32826-3714
PMA NumberP930034
Supplement NumberS015
Date Received01/06/2000
Decision Date02/03/2000
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change tradename to Infinity LS Excimer Laser System
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