Approval for the hydrus® microstent. This device is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (iop) in adult patients with mild to moderate primary open-angle glaucoma (poag).
| Device | HYDRUS MICROSTENT |
| Classification Name | Intraocular Pressure Lowering Implant |
| Generic Name | Intraocular Pressure Lowering Implant |
| Applicant | Ivantis, Inc. |
| Date Received | 2017-10-30 |
| Decision Date | 2018-08-10 |
| Notice Date | 2018-08-13 |
| PMA | P170034 |
| Supplement | S |
| Product Code | OGO |
| Docket Number | 18M-3153 |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Ivantis, Inc. 38 Discovery, Suite 150 irvine, CA 92618 |
| 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 |
|---|---|---|
| P170034 | Original Filing | |
| S007 | 2021-11-03 | 30-day Notice |
| S006 | 2020-12-10 | 30-day Notice |
| S005 | ||
| S004 | 2019-11-27 | Normal 180 Day Track No User Fee |
| S003 | 2019-08-27 | Normal 180 Day Track No User Fee |
| S002 | 2019-07-24 | Normal 180 Day Track No User Fee |
| S001 | 2018-09-07 | Normal 180 Day Track No User Fee |
| Device ID | PMA | Supp |
|---|---|---|
| 20867487000138 | P170034 | 000 |