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Device | BAUSCH& LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM |
Generic Name | Excimer laser system |
Applicant | TECHNOLAS PERFECT VISION GMBH MESSERSCHMITTSTR 1 + 3 MUNCHEN 80992 |
PMA Number | P990027 |
Supplement Number | S009 |
Date Received | 12/19/2006 |
Decision Date | 02/01/2008 |
Product Code |
LZS |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE EXPANSION OF THE PHYSICIAN ADJUSTMENT RANGE FOR THE SPHERICAL COMPONENT ROM +2.5 D TO -1.0 D. |