PMA
P070027: THE TALENT ABDOMINAL STENT GRAFT SYSTEM
FDA PMA · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT · Medtronic Vascular
Key facts
| PMA number | P070027 |
|---|---|
| Trade name | THE TALENT ABDOMINAL STENT GRAFT SYSTEM |
| Generic name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
| Applicant | Medtronic Vascular |
| Owner/operator | Medtronic, Inc. |
| Product code | MIH |
| Approval date | Apr 15, 2008 |
| Docket number | 08M-0244 |
| Notice date | Apr 24, 2008 |
| Establishment registration | 2953200 |
| FEI number | 3001452571 |
At a glance
- 10–99 Supplements
- Feb 1, 2017 Latest supplement decision
- Yes Withdrawn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: