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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 SYSTEMS
Generic NameExcimer laser system
ApplicantAlcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX 76134-2099
PMA NumberP020050
Supplement NumberS007
Date Received03/12/2012
Decision Date04/11/2012
Product Code LZS 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL OF A PMA SUPPLEMENT FOR THE FOLLOWING THREE CHANGES FROM THE ANNUAL REPORT, 2011: 1) ALTERNATE SOURCE SUPPLIER FOR VENTILATOR; 2) MODIFIED PACKAGING OF OPTICAL ELEMENTS: AND 3) NEW SUPPLIER FOR SMART CARDS.
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