This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | Hydrus Microstent |
| Classification Name | Intraocular Pressure Lowering Implant |
| Generic Name | Intraocular Pressure Lowering Implant |
| Applicant | Ivantis, Inc. |
| Date Received | 2018-09-07 |
| Decision Date | 2019-10-08 |
| PMA | P170034 |
| Supplement | S001 |
| Product Code | OGO |
| 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 | Ivantis, Inc. 38 Discovery, Suite 150 irvine, CA 92618 |
| 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 |