|
Device | INTACS PRESCRIPTION INSERTS/INTACS CORNEAL IMPLANTS |
Generic Name | Implant, corneal, refractive |
Applicant | ADDITION TECHNOLOGY 820 OAK CREEK DRIVE LOMBARD, IL 60148 |
PMA Number | P980031 |
Date Received | 07/14/1998 |
Decision Date | 04/09/1999 |
Product Code |
LQE |
Docket Number | 99M-1167 |
Advisory Committee |
Ophthalmic |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement This device is indicated for the reduction or elimination of mild myopia (-2.00 to -3.00 diopters spherical equivalent at the spectacle plane) in patients: who are 21 yrs of age or older; with documented stability of refraction as demonstrated by a change of less than or equal to 0.50D for at least 12 months prior to the preoperative examination; and where the astigmatic components are +1.00D or less. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S011 S012 S013 |