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. |
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Device | LASERSCAN LSX EXCIMER LASER |
Generic Name | Excimer laser system |
Applicant | LASERSIGHT TECHNOLOGIES, INC. 6903 UNIVERSITY BLVD., WINTER PARK, FL 32792 |
PMA Number | P980008 |
Supplement Number | S002 |
Date Received | 07/13/2000 |
Decision Date | 10/27/2000 |
Product Code |
LZS |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT LASERSIGHT TECHNOLOGIES, INC., WINTER PARK, FLORIDA. |
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