PMA
P060033: ENDEAVOR ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM
FDA PMA · Coronary drug-eluting stent · Medtronic, Inc.
Key facts
| PMA number | P060033 |
|---|---|
| Trade name | ENDEAVOR ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM |
| Generic name | Coronary drug-eluting stent |
| Applicant | Medtronic, Inc. |
| Owner/operator | Medtronic, Inc. |
| Product code | NIQ |
| Approval date | Feb 1, 2008 |
| Docket number | 08M-0109 |
| Notice date | Feb 12, 2008 |
| Establishment registration | 2953200 |
| FEI number | 3001452571 |
At a glance
- 10–99 Supplements
- Dec 10, 2014 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- Yes Withdrawn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: