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Device | ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM |
Generic Name | Excimer laser system |
Applicant | Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134-2099 |
PMA Number | P020050 |
Supplement Number | S008 |
Date Received | 07/30/2012 |
Decision Date | 09/07/2012 |
Product Code |
LZS |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR INTRODUCTION OF A NEW NOTEBOOK COMPUTER MODEL(TOSHIBA TECRA A11) TO REPLACE THE CURRENT NOTEBOOK MODEL (TOSHIBA TECRA M10) WHICH IS BEING PHASED OUT BY THE MANUFACTURER. THIS WILL REQUIRE A CHANGE IN THE OPERATING SYSTEM FROM WINDOWS 2000 TO WINDOWS XP SERVICE PACK 2 AS THE NEW NOTEBOOK COMPUTER WILL NOT BESUPPORTED BY THE OLD SYSTEM. |