PMA
P120002: SMA RT CONTROL AND SMART VASCULAR STENT SYSTEMS
FDA PMA · STENT, SUPERFICIAL FEMORAL ARTERY · Cordis US Corporation
Key facts
| PMA number | P120002 |
|---|---|
| Trade name | SMA RT CONTROL AND SMART VASCULAR STENT SYSTEMS |
| Generic name | STENT, SUPERFICIAL FEMORAL ARTERY |
| Applicant | Cordis US Corporation |
| Owner/operator | Cordis US Corp. |
| Product code | NIP |
| Approval date | Nov 7, 2012 |
| Docket number | 12M-1183 |
| Notice date | Dec 5, 2012 |
| Establishment registration | 1016427 |
| FEI number | 1016427 |
At a glance
- 10–99 Supplements
- Jan 8, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 100–999 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: