PMA
P160043: RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
FDA PMA · Coronary drug-eluting stent · Medtronic Vascular
Key facts
| PMA number | P160043 |
|---|---|
| Trade name | RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM |
| Generic name | Coronary drug-eluting stent |
| Applicant | Medtronic Vascular |
| Owner/operator | Medtronic, Inc. |
| Product code | NIQ |
| Approval date | Apr 28, 2017 |
| Docket number | 17M-2767 |
| Notice date | May 2, 2017 |
| Establishment registration | 2953200 |
| FEI number | 3001452571 |
At a glance
- 10–99 Supplements
- Aug 14, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 100–999 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: