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Device | SVS APEX PLUS EXCIMER LASER WORKSTATION |
Generic Name | Excimer laser system |
Applicant | Alcon Laboratories, Inc. 2501 DISCOVERY DRIVE,SUITE 500 ORLANDO, FL 32826-3714 |
PMA Number | P930034 |
Supplement Number | S013 |
Date Received | 02/11/1999 |
Decision Date | 10/21/1999 |
Withdrawal Date
|
05/18/2010 |
Product Code |
LZS |
Docket Number | 00M-1591 |
Notice Date | 11/03/2000 |
Advisory Committee |
Ophthalmic |
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | Yes |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE SVS APEX PLUS EXCIMER LASER WORKSTATION AND EMPHASIS(R) "M" DISCS (M00-M09) THESE DEVICES ARE INDICATED TO PERFORM LASIK: 1) FOR THE REDUCTION OR ELIMINATION OF MYOPIA RANGING FROM 0.0 TO -14.0 DIOPTERS (D) WITH OR WITHOUT ASTIGMATISM RANGING FROM -0.5D TO -5.0D; 2) IN PATIENTS 18 YEARS OF AGE OR OLDER; AND 3) IN PATIENTS WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION (+0.5D) OVER THE PAST YEAR. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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