PMA
P110011: ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM
FDA PMA · STENT, ILIAC · Medtronic, Ireland
Key facts
| PMA number | P110011 |
|---|---|
| Trade name | ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM |
| Generic name | STENT, ILIAC |
| Applicant | Medtronic, Ireland |
| Owner/operator | Medtronic, Inc. |
| Product code | NIO |
| Approval date | Oct 26, 2011 |
| Docket number | 11M-0791 |
| Notice date | Nov 4, 2011 |
| Establishment registration | 9612164 |
| FEI number | 3002806434 |
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- Yes Withdrawn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: