PMA
P000033: INTRA COIL SELF-EXPANDING PERIPHERAL STENT
FDA PMA · STENT, SUPERFICIAL FEMORAL ARTERY · Medtronic Vascular, Inc.
Key facts
| PMA number | P000033 |
|---|---|
| Trade name | INTRA COIL SELF-EXPANDING PERIPHERAL STENT |
| Generic name | STENT, SUPERFICIAL FEMORAL ARTERY |
| Applicant | Medtronic Vascular, Inc. |
| Owner/operator | Medtronic, Inc. |
| Product code | NIP |
| Approval date | Apr 3, 2002 |
| Docket number | 02M-0235 |
| Notice date | May 24, 2002 |
| Establishment registration | 1220452 |
| FEI number | 1220452 |
At a glance
- 1–9 Supplements
- Jul 7, 2005 Latest supplement decision
- Yes Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: