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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceAMDS Hybrid Prosthesis
Generic NameHybrid stent graft, thoracic aortic lesion treatment
ApplicantArtivion, Inc.
1655 Roberts Blvd. NW
Kennesaw, GA 30144
PMA NumberP250055
Date Received12/29/2025
Decision Date06/26/2026
Product Code QSK 
Advisory Committee Cardiovascular
Clinical TrialsNCT03035643
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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.
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