PMA
P140002: MISAGO PERIPHERAL SELF-EXPANDING STENT SYSTEM
FDA PMA · STENT, SUPERFICIAL FEMORAL ARTERY · Terumo Medical Corporation
Key facts
| PMA number | P140002 |
|---|---|
| Trade name | MISAGO PERIPHERAL SELF-EXPANDING STENT SYSTEM |
| Generic name | STENT, SUPERFICIAL FEMORAL ARTERY |
| Applicant | Terumo Medical Corporation |
| Owner/operator | TERUMO MEDICAL CORP. |
| Product code | NIP |
| Approval date | May 22, 2015 |
| Docket number | 15M-1958 |
| Notice date | Jun 5, 2015 |
| Establishment registration | 2243441 |
| FEI number | 2243441 |
At a glance
- 10–99 Supplements
- Jul 16, 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- No Withdrawn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: