PMA
P020007: MEDTRONIC AVE BRIDGE EXTRA SUPPORT OVER THE WIRE RENAL STENT SYSTEM
FDA PMA · STENT, RENAL · Medtronic Vascular
Key facts
| PMA number | P020007 |
|---|---|
| Trade name | MEDTRONIC AVE BRIDGE EXTRA SUPPORT OVER THE WIRE RENAL STENT SYSTEM |
| Generic name | STENT, RENAL |
| Applicant | Medtronic Vascular |
| Owner/operator | Medtronic, Inc. |
| Product code | NIN |
| Approval date | Dec 18, 2002 |
| Docket number | 03M-0487 |
| Notice date | Oct 28, 2003 |
| Establishment registration | 2953200 |
| FEI number | 3001452571 |
At a glance
- 1–9 Supplements
- May 15, 2003 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- Yes Withdrawn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: