PMA
P250055: AMDS Hybrid Prosthesis
FDA PMA · Hybrid stent graft, thoracic aortic lesion treatment · Artivion, Inc.
Key facts
| PMA number | P250055 |
|---|---|
| Trade name | AMDS Hybrid Prosthesis |
| Generic name | Hybrid stent graft, thoracic aortic lesion treatment |
| Applicant | Artivion, Inc. |
| Product code | QSK |
| Approval date | Jun 26, 2026 |
At a glance
- None Supplements
- Jun 26, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 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: