Approval for the customflex artificial iris. The customflex artificial iris is indicated for use in children and adults for the treatment of full or partial aniridia resulting from congenital aniridia, acquired defects, or other conditions associated with full or partial aniridia.
| Device | CustomFlex Artificial Iris |
| Classification Name | Artificial Iris |
| Generic Name | Artificial Iris |
| Applicant | Clinical Research Consultants, Inc. |
| Date Received | 2017-11-29 |
| Decision Date | 2018-05-30 |
| PMA | P170039 |
| Supplement | S |
| Product Code | QBT |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Clinical Research Consultants, Inc. 3308 Jefferson Avenue, Upper Level cincinnati, OH 45220 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P170039 | Original Filing | |
| S003 | 2019-09-25 | 135 Review Track For 30-day Notice |
| S002 | 2018-07-19 | Normal 180 Day Track No User Fee |
| S001 | 2018-07-10 | Normal 180 Day Track No User Fee |
| Device ID | PMA | Supp |
|---|---|---|
| 04049154000029 | P170039 | 000 |
| 04049154000012 | P170039 | 000 |