PMA
P120003: iCast Covered Stent System
FDA PMA · Iliac covered stent, arterial · Atrium Medical Corp.
Key facts
| PMA number | P120003 |
|---|---|
| Trade name | iCast Covered Stent System |
| Generic name | Iliac covered stent, arterial |
| Applicant | Atrium Medical Corp. |
| Owner/operator | ATRIUM MEDICAL CORPORATION |
| Product code | PRL |
| Approval date | Mar 22, 2023 |
| Docket number | 23M-1104 |
| Notice date | Apr 11, 2023 |
| Establishment registration | 3011175548 |
| FEI number | 3011175548 |
At a glance
- 10–99 Supplements
- May 13, 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- No Withdrawn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: