ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM
FDA premarket approval P020050/S008 · decided 2012-09-07
Approval details
- PMA number
- P020050
- Supplement
- S008
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2012-07-30
- Decision date
- 2012-09-07
- Days to decision
- 39 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- 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.
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