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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.
 
DeviceLASERSCAN LSX EXCIMER LASER
Generic NameExcimer laser system
ApplicantLasersight Technologies, Inc.
6903 University Blvd.,
Winter Park, FL 32792
PMA NumberP980008
Supplement NumberS002
Date Received07/13/2000
Decision Date10/27/2000
Product Code LZS 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT LASERSIGHT TECHNOLOGIES, INC., WINTER PARK, FLORIDA.
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