AMDS Hybrid Prosthesis
FDA premarket approval P250055 · decided 2026-06-26
Approval details
- PMA number
- P250055
- Trade name
- AMDS Hybrid Prosthesis
- Generic name
- Hybrid stent graft, thoracic aortic lesion treatment
- Applicant
- Artivion, Inc.
- Date received
- 2025-12-29
- Decision date
- 2026-06-26
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- QSK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Kennesaw, GA
- Statement
- The AMDS Hybrid Prosthesis is indicated for use in patients with acute DeBakey Type I aortic dissections with malperfusion (including cerebral, visceral, renal, and peripheral malperfusion) and a primary entry tear within the ascending aorta proximal to the innominate artery, who are undergoing open surgical repair within 0-14 days of diagnosis.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00) (K252059) | Artivion, Inc. | 2025-10-02 |