Approval of the protocol for the post-approval study (pas) referenced above. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for p170039.
| Device | CustomFlex Artificial Iris |
| Classification Name | Artificial Iris |
| Generic Name | Artificial Iris |
| Applicant | Clinical Research Consultants, Inc. |
| Date Received | 2018-07-10 |
| Decision Date | 2019-09-23 |
| PMA | P170039 |
| Supplement | S001 |
| Product Code | QBT |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Ode/oir |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Clinical Research Consultants, Inc. 3308 Jefferson Avenue, Upper Level cincinnati, OH 45220 |
Supplemental Filings
| 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 |
NIH GUDID Devices