PMA supplement
P140002 S032: MISAGO(TM) RX Self-expanding Peripheral Stent
FDA PMA supplement · Panel Track · Terumo Medical Corporation
Key facts
| Original PMA | P140002 |
|---|---|
| Supplement number | S032 |
| Supplement type | Panel Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | MISAGO(TM) RX Self-expanding Peripheral Stent |
| Generic name | STENT, ILIAC |
| Applicant | Terumo Medical Corporation |
| Product code | NIO |
| Received date | Dec 29, 2025 |
| Decision date | Jul 16, 2026 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: