PMA
P180003: BioMimics 3D Vascular Stent System
FDA PMA · STENT, SUPERFICIAL FEMORAL ARTERY · Veryan Medical, Ltd.
Key facts
| PMA number | P180003 |
|---|---|
| Trade name | BioMimics 3D Vascular Stent System |
| Generic name | STENT, SUPERFICIAL FEMORAL ARTERY |
| Applicant | Veryan Medical, Ltd. |
| Owner/operator | Veryan |
| Product code | NIP |
| Approval date | Oct 4, 2018 |
| Docket number | 18M-3841 |
| Notice date | Oct 19, 2018 |
| Establishment registration | 3011632150 |
| FEI number | 3011632150 |
At a glance
- 10–99 Supplements
- Feb 19, 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- No Withdrawn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: