PMA
P170034: HYDRUS MICROSTENT
FDA PMA · Intraocular pressure lowering implant · Alcon Research, LLC
Key facts
| PMA number | P170034 |
|---|---|
| Trade name | HYDRUS MICROSTENT |
| Generic name | Intraocular pressure lowering implant |
| Applicant | Alcon Research, LLC |
| Owner/operator | Alcon Laboratories, Inc. |
| Product code | OGO |
| Approval date | Aug 10, 2018 |
| Docket number | 18M-3153 |
| Notice date | Aug 13, 2018 |
| Establishment registration | 1610287 |
| FEI number | 1610287 |
At a glance
- 10–99 Supplements
- Jun 4, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: