PMA
P140016: ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT
FDA PMA · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT · Cook Medical Incorporated
Key facts
| PMA number | P140016 |
|---|---|
| Trade name | ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT |
| Generic name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
| Applicant | Cook Medical Incorporated |
| Owner/operator | COOK MEDICAL |
| Product code | MIH |
| Approval date | Sep 15, 2015 |
| Docket number | 15M-3377 |
| Notice date | Oct 15, 2015 |
| Establishment registration | 3005580113 |
| FEI number | 3005580113 |
At a glance
- 10–99 Supplements
- Aug 4, 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- No Withdrawn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: