PMA
P240003: Minima Stent System and Minima Pro Stent System
FDA PMA · Aortic stent · Renata Medical, Inc.
Key facts
| PMA number | P240003 |
|---|---|
| Trade name | Minima Stent System and Minima Pro Stent System |
| Generic name | Aortic stent |
| Applicant | Renata Medical, Inc. |
| Owner/operator | Renata Medical |
| Product code | PNF |
| Approval date | Aug 28, 2024 |
| Establishment registration | 3027098402 |
| FEI number | 3027098402 |
At a glance
- 1–9 Supplements
- Aug 27, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 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: