PMA
P170032: Woven EndoBridge (WEB) Aneurysm Embolization System
FDA PMA · Intrasaccular Flow Disruption Device · MicroVention, Inc.
Key facts
| PMA number | P170032 |
|---|---|
| Trade name | Woven EndoBridge (WEB) Aneurysm Embolization System |
| Generic name | Intrasaccular Flow Disruption Device |
| Applicant | MicroVention, Inc. |
| Owner/operator | MicroVention Inc. |
| Product code | OPR |
| Approval date | Dec 31, 2018 |
| Docket number | 19M-0027 |
| Notice date | Jan 28, 2019 |
| Establishment registration | 3013556777 |
| FEI number | 3013556777 |
At a glance
- 10–99 Supplements
- May 28, 2026 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- No Withdrawn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: