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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.
 
DeviceALLEGRETTO WAVE EXCIMER LASER SYSTEM
Generic NameExcimer laser system
ApplicantAlcon Laboratories, Inc.
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP020050
Supplement NumberS002
Date Received01/31/2005
Decision Date02/15/2005
Product Code LZS 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR NOTEBOOK SOFTWARE CHANGES TO THE NEW SOFTWARE VERSION (NB-042201) THAT INVOLVE: 1) A CHANGE IN THE NOTATION USED TO ENTER REFRACTION; AND 2) THE SOFTWARE MENU LOCATION AT WHICH USERS MAY SELECT DIFFERENT VALUES FOR FLAP THICKNESS BASED ON THE TYPE OF MICROKERATOME USED TO CREATE CORNEAL FLAPS.
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