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 the modifications to the model gts100i inserter and stent, which comprise the istent trabecular micro-bypass stent system. The modifications include thefollowing:1) changes to the inserter to include:a) a larger sleeve diameter for increased rigidity of the slide assembly;b) an increase in the internal spring force; c) a change to the geometry and extension of the grasping tines on the end of the slotted tube; d) a re-design of the release button rocker mechanism; and e) color changes to two outer inserter components (rear housing and trigger button). 2) changes to the stent to include:a) an increase in the wall thickness of the snorkel by tightening the dimensional tolerance from a range 0. 155 to 0. 200 mm to a range of 0. 170 to 0. 200 mm; and b) removal of the stenting height parameter from the finished device drawings 10-0018 and 10-0019 as a critical dimension. 3) changes to the stent system to include:a) a change from sterilization following primary packaging to sterilization following final packaging; and b) elimination of the in-process grip force testing step.
| Device | GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM |
| Classification Name | Intraocular Pressure Lowering Implant |
| Generic Name | Intraocular Pressure Lowering Implant |
| Applicant | GLAUKOS, CORPORATION |
| Date Received | 2014-09-30 |
| Decision Date | 2014-12-16 |
| PMA | P080030 |
| Supplement | S012 |
| Product Code | OGO |
| 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 |