PMA
P080030: GLAUKOS ISTENT TRABECULAR BYPASS STENT MODEL GTS100R/L
FDA PMA · Intraocular pressure lowering implant · Glaukos Corporation
Key facts
| PMA number | P080030 |
|---|---|
| Trade name | GLAUKOS ISTENT TRABECULAR BYPASS STENT MODEL GTS100R/L |
| Generic name | Intraocular pressure lowering implant |
| Applicant | Glaukos Corporation |
| Owner/operator | GLAUKOS CORP. |
| Product code | OGO |
| Approval date | Jun 25, 2012 |
| Docket number | 12M-0712 |
| Notice date | Jul 16, 2012 |
| Establishment registration | 3012833022 |
| FEI number | 3012341472 |
At a glance
- 10–99 Supplements
- Apr 8, 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- No Withdrawn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: