This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the istent inject® trabecular micro-bypass system (model g2-m-is). 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.
| Device | iStent inject Trabecular Micro-Bypass System (Model G2-M-IS) |
| Classification Name | Intraocular Pressure Lowering Implant |
| Generic Name | Intraocular Pressure Lowering Implant |
| Applicant | Glaukos Corporation |
| Date Received | 2017-12-21 |
| Decision Date | 2018-06-21 |
| Notice Date | 2018-07-09 |
| PMA | P170043 |
| Supplement | S |
| Product Code | OGO |
| Docket Number | 18M-2460 |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Glaukos Corporation 229 Avenida Fabricante san Clemente, CA 92672 |
| 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 |
|---|---|---|
| P170043 | Original Filing | |
| S014 | 2022-05-31 | Normal 180 Day Track |
| S013 | ||
| S012 | 2022-02-04 | 30-day Notice |
| S011 | ||
| S010 | 2021-06-15 | Normal 180 Day Track |
| S009 | 2021-03-25 | 135 Review Track For 30-day Notice |
| S008 | 2020-12-07 | Normal 180 Day Track No User Fee |
| S007 | 2020-03-03 | Normal 180 Day Track No User Fee |
| S006 | 2020-03-03 | Normal 180 Day Track No User Fee |
| S005 | ||
| S004 | 2019-05-02 | 30-day Notice |
| S003 | ||
| S002 | 2018-07-23 | Normal 180 Day Track No User Fee |
| S001 | 2018-07-23 | Normal 180 Day Track No User Fee |
| Device ID | PMA | Supp |
|---|---|---|
| 00853704002203 | P170043 | 000 |
| 00853704002319 | P170043 | 005 |