PMA
P230021: Duo Venous Stent System
FDA PMA · Stent, iliac vein · Philips Image Guided Therapy Corporation
Key facts
| PMA number | P230021 |
|---|---|
| Trade name | Duo Venous Stent System |
| Generic name | Stent, iliac vein |
| Applicant | Philips Image Guided Therapy Corporation |
| Owner/operator | Philips Medical Systems International BV |
| Product code | QAN |
| Approval date | Dec 26, 2023 |
| Docket number | 24M-0045 |
| Notice date | Jan 10, 2024 |
| Establishment registration | 3016257349 |
| FEI number | 3016257349 |
At a glance
- 1–9 Supplements
- Aug 26, 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- No Withdrawn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: