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 Corporation229 Avenida Fabricantesan Clemente, CA 92672 PMA NumberP170043 Supplement NumberS014 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 | P170043 |
| Supplement | S014 |
| 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 229 Avenida Fabricante san Clemente, CA 92672 PMA NumberP170043 Supplement NumberS014 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 Approval Order Statement approval For An Alternate Supplier And Modifications To The Specifications And Incoming Receiving Testing For The Stearalkonium Heparin Coating Raw Material |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00853704002203 | P170043 | 000 |
| 00853704002319 | P170043 | 005 |