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.
Approval for two alternate packaging configurations that include an ophthalmic clip.
| Device | iStent Trabecular Micro-Bypass Stent System |
| Classification Name | Intraocular Pressure Lowering Implant |
| Generic Name | Intraocular Pressure Lowering Implant |
| Applicant | GLAUKOS, CORPORATION |
| Date Received | 2018-03-01 |
| Decision Date | 2018-05-29 |
| PMA | P080030 |
| Supplement | S021 |
| Product Code | OGO |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | GLAUKOS, CORPORATION 26051 Merit Circle, Suite 103 laguna Hills, CA 92653 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P080030 | Original Filing | |
| S024 | 2022-05-31 | Normal 180 Day Track |
| S023 | 2022-02-04 | 30-day Notice |
| S022 | 2018-11-21 | 30-day Notice |
| S021 | 2018-03-01 | Normal 180 Day Track |
| S020 | 2017-02-13 | Normal 180 Day Track |
| S019 | 2016-11-07 | 30-day Notice |
| S018 | 2015-12-15 | Normal 180 Day Track No User Fee |
| S017 | 2015-05-26 | Normal 180 Day Track No User Fee |
| S016 | 2015-05-22 | Normal 180 Day Track No User Fee |
| S015 | ||
| S014 | 2015-02-11 | Real-time Process |
| S013 | 2015-02-09 | Normal 180 Day Track No User Fee |
| S012 | 2014-09-30 | Normal 180 Day Track |
| S011 | 2014-08-01 | 30-day Notice |
| S010 | 2013-07-30 | 30-day Notice |
| S009 | 2013-05-23 | 30-day Notice |
| S008 | 2013-04-05 | 30-day Notice |
| S007 | 2013-02-19 | 30-day Notice |
| S006 | 2012-08-21 | 30-day Notice |
| S005 | 2012-07-20 | Normal 180 Day Track No User Fee |
| S004 | 2012-07-20 | Normal 180 Day Track No User Fee |
| S003 | 2012-07-20 | Normal 180 Day Track No User Fee |
| S002 | 2012-07-09 | 135 Review Track For 30-day Notice |
| S001 | 2012-06-29 | 135 Review Track For 30-day Notice |