A modification to the endotoxin specification for the injector handpiece for the glaukos® istent inject® trabecular micro-bypass system (model g2-m-is)
| 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 | 2019-05-02 |
| Decision Date | 2019-05-30 |
| PMA | P170043 |
| Supplement | S004 |
| Product Code | OGO |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Glaukos Corporation 229 Avenida Fabricante san Clemente, CA 92672 |
Supplemental Filings
| 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 |
NIH GUDID Devices