PMA
P180027: Flow Re-Direction Endoluminal Device (FRED®) System
FDA PMA · Intracranial aneurysm flow diverter · MicroVention, Inc.
Key facts
| PMA number | P180027 |
|---|---|
| Trade name | Flow Re-Direction Endoluminal Device (FRED®) System |
| Generic name | Intracranial aneurysm flow diverter |
| Applicant | MicroVention, Inc. |
| Owner/operator | MicroVention Inc. |
| Product code | OUT |
| Approval date | Dec 16, 2019 |
| Docket number | 19M-5961 |
| Notice date | Dec 18, 2019 |
| Establishment registration | 3013556777 |
| FEI number | 3013556777 |
At a glance
- 10–99 Supplements
- Nov 2, 2025 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: