PMA P250055
- Device
- AMDS Hybrid Prosthesis
- Applicant
- Artivion, Inc.
- PMA number
- P250055
- Product code
- QSK
- Decision date
- 2026-06-26
- Classification
- Cardiovascular
- Generic name
- Hybrid stent graft, thoracic aortic lesion treatment
- Approval order 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.
Current openFDA PMA Record#
- Device
- AMDS Hybrid Prosthesis
- Applicant
- Artivion, Inc.
- PMA number
- P250055
- Product code
- QSK
- Generic name
- Hybrid stent graft, thoracic aortic lesion treatment
- Decision date
- 2026-06-26
- Decision code
- APPR
- Date received
- 2025-12-29
- Approval order 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.