PMA
P210006: Thoraflex™ Hybrid
FDA PMA · Hybrid stent graft, thoracic aortic lesion treatment · Vascutek, Ltd.
Key facts
| PMA number | P210006 |
|---|---|
| Trade name | Thoraflex™ Hybrid |
| Generic name | Hybrid stent graft, thoracic aortic lesion treatment |
| Applicant | Vascutek, Ltd. |
| Owner/operator | VASCUTEK LTD. |
| Product code | QSK |
| Approval date | Apr 19, 2022 |
| Docket number | 22M-0632 |
| Notice date | Apr 21, 2022 |
| Establishment registration | 9612515 |
| FEI number | 3002808437 |
At a glance
- 10–99 Supplements
- Sep 8, 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- No Withdrawn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: