PMA
P180001: Zenith Dissection Endovascular System
FDA PMA · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT · William Cook Europe Aps
Key facts
| PMA number | P180001 |
|---|---|
| Trade name | Zenith Dissection Endovascular System |
| Generic name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
| Applicant | William Cook Europe Aps |
| Owner/operator | WILLIAM COOK EUROPE APS |
| Product code | MIH |
| Approval date | Dec 31, 2018 |
| Docket number | 19M-0028 |
| Notice date | Jan 25, 2019 |
| Establishment registration | 3002808486 |
| FEI number | 3002808486 |
At a glance
- 10–99 Supplements
- Aug 4, 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- No Withdrawn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: