PMA
P170043: iStent inject Trabecular Micro-Bypass System (Model G2-M-IS)
FDA PMA · Intraocular pressure lowering implant · Glaukos Corporation
Key facts
| PMA number | P170043 |
|---|---|
| Trade name | iStent inject Trabecular Micro-Bypass System (Model G2-M-IS) |
| Generic name | Intraocular pressure lowering implant |
| Applicant | Glaukos Corporation |
| Owner/operator | GLAUKOS CORP. |
| Product code | OGO |
| Approval date | Jun 21, 2018 |
| Docket number | 18M-2460 |
| Notice date | Jul 9, 2018 |
| Establishment registration | 3012833022 |
| FEI number | 3012341472 |
At a glance
- 10–99 Supplements
- Oct 1, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: