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 | iStent Trabecular Micro-Bypass Stent System, iStent inject Trabecular Micro-Bypass System, iStent inject W Trabecular Mi |
| Generic Name | Intraocular Pressure Lowering Implant |
| Applicant | GLAUKOS, CORPORATION26051 Merit Circle, Suite 103laguna Hills, CA 92653 PMA NumberP080030 Supplement NumberS024 Date Received05/31/2022 Decision Date08/29/2022 Product Code OGO Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-05-31 |
| Decision Date | 2022-08-29 |
| PMA | P080030 |
| Supplement | S024 |
| Product Code | OGO |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | GLAUKOS, CORPORATION 26051 Merit Circle, Suite 103 laguna Hills, CA 92653 PMA NumberP080030 Supplement NumberS024 Date Received05/31/2022 Decision Date08/29/2022 Product Code OGO Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo |
| 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 |