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 glaukos istent® trabecular micro-bypass stent (models: gts-100r, gts-100l) and inserter (gts-l00i). This device is indicated for use in conjunction with cataract surgery for the reduction ofintraocular pressure (iop) in adult patients with mild to moderate open-angle glaucoma currently treated with ocular hypotensive medication.
| Device | GLAUKOS ISTENT TRABECULAR BYPASS STENT MODEL GTS100R/L |
| Classification Name | Intraocular Pressure Lowering Implant |
| Generic Name | Intraocular Pressure Lowering Implant |
| Applicant | GLAUKOS, CORPORATION |
| Date Received | 2008-12-19 |
| Decision Date | 2012-06-25 |
| Notice Date | 2012-07-16 |
| PMA | P080030 |
| Supplement | S |
| Product Code | OGO |
| Docket Number | 12M-0712 |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | GLAUKOS, CORPORATION 26051 Merit Circle, Suite 103 laguna Hills, CA 92653 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |