PMA
P110043: OMNILINK ELITE PERIPHERAL BALLOON-EXPANDABLE STENT SYSTEM
FDA PMA · STENT, ILIAC · Abbott Vascular-Cardiac Therapies
Key facts
| PMA number | P110043 |
|---|---|
| Trade name | OMNILINK ELITE PERIPHERAL BALLOON-EXPANDABLE STENT SYSTEM |
| Generic name | STENT, ILIAC |
| Applicant | Abbott Vascular-Cardiac Therapies |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | NIO |
| Approval date | Jul 31, 2012 |
| Docket number | 12M-0833 |
| Notice date | Aug 3, 2012 |
| Establishment registration | 2939561 |
| FEI number | 3004635528 |
At a glance
- 10–99 Supplements
- Jan 12, 2026 Latest supplement decision
- No Withdrawn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: