PMA supplement
P210006 S016: Thoraflex™ Hybrid
FDA PMA supplement · Special (Immediate Track) · Vascutek, Ltd.
Key facts
| Original PMA | P210006 |
|---|---|
| Supplement number | S016 |
| Supplement type | Special (Immediate Track) |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Thoraflex™ Hybrid |
| Generic name | Hybrid stent graft, thoracic aortic lesion treatment |
| Applicant | Vascutek, Ltd. |
| Product code | QSK |
| Received date | Dec 30, 2025 |
| Decision date | Jan 29, 2026 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: