AMDS Hybrid Prosthesis
Device Facts
| Record ID | P250055 |
|---|---|
| Device Name | AMDS Hybrid Prosthesis |
| Applicant | Artivion, Inc. |
| Product Code | QSK |
| Decision Date | Jun 26, 2026 |
| Decision | APPR |
| Device Class | Class 3 |
Regulatory Classification
Identification
Repair or replacement of damaged or diseased vessel of the aortic arch and descending thoracic aorta, with or without involvement of ascending aorta, using vascular grafts and/or stent grafts placed during open surgical repair.
