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Device | LADARVISION EXCIMER LASER SYSTEM |
Generic Name | Excimer laser system |
Applicant | ALCON LABORATORIES 6201 S FREEWAY FT WORTH, TX 76134 |
PMA Number | P970043 |
Supplement Number | S005 |
Date Received | 09/03/1999 |
Decision Date | 05/09/2000 |
Withdrawal Date
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05/15/2012 |
Product Code |
LZS |
Docket Number | 00M-1593 |
Notice Date | 11/14/2000 |
Advisory Committee |
Ophthalmic |
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the LADARVision Excimer Laser System indicated for laser in-situ keratomileusis (LASIK). |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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