PMA
P070016: ZENITH TX2 THORACIC TAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM
FDA PMA · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT · William Cook Europe Aps
Key facts
| PMA number | P070016 |
|---|---|
| Trade name | ZENITH TX2 THORACIC TAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION 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 | May 21, 2008 |
| Docket number | 08M-0311 |
| Notice date | May 27, 2008 |
| Establishment registration | 3002808486 |
| FEI number | 3002808486 |
At a glance
- 10–99 Supplements
- Oct 10, 2018 Latest supplement decision
- Yes Withdrawn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: