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.
| Device | INTACS PRESCRIPTION INSERTS/INTACS CORNEAL IMPLANTS |
| Classification Name | Implant, Corneal, Refractive |
| Generic Name | Implant, Corneal, Refractive |
| Applicant | ADDITION TECHNOLOGY |
| Date Received | 1998-07-14 |
| Decision Date | 1999-04-09 |
| PMA | P980031 |
| Supplement | S |
| Product Code | LQE |
| Docket Number | 99M-1167 |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ADDITION TECHNOLOGY 820 Oak Creek Drive lombard, IL 60148 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P980031 | | Original Filing |
| S012 |
2012-12-12 |
135 Review Track For 30-day Notice |
| S011 |
2012-11-14 |
30-day Notice |
| S010 | | |
| S009 |
2005-10-31 |
30-day Notice |
| S008 |
2004-06-10 |
Normal 180 Day Track No User Fee |
| S007 |
2004-05-19 |
Normal 180 Day Track No User Fee |
| S006 |
2003-05-14 |
Normal 180 Day Track No User Fee |
| S005 |
2003-05-02 |
30-day Notice |
| S004 |
2000-02-23 |
Normal 180 Day Track |
| S003 |
2000-02-22 |
30-day Notice |
| S002 |
1999-12-23 |
30-day Notice |
| S001 |
1999-11-03 |
30-day Notice |
NIH GUDID Devices