PMA
P150037: CyPass Micro-Stent
FDA PMA · Intraocular pressure lowering implant · Alcon Research, Ltd.
Key facts
| PMA number | P150037 |
|---|---|
| Trade name | CyPass Micro-Stent |
| Generic name | Intraocular pressure lowering implant |
| Applicant | Alcon Research, Ltd. |
| Owner/operator | Alcon Laboratories, Inc. |
| Product code | OGO |
| Approval date | Jul 29, 2016 |
| Docket number | 16M-2333 |
| Notice date | Aug 18, 2016 |
| Establishment registration | 2523835 |
| FEI number | 2523835 |
At a glance
- 10–99 Supplements
- Apr 9, 2020 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- No Withdrawn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: