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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Trade NameAMDS Hybrid Prosthesis
Classification Namehybrid stent graft, thoracic aortic lesion treatment
Generic Namehybrid stent graft, thoracic aortic lesion treatment
Applicant
Artivion, Inc.
1655 roberts blvd. nw
kennesaw, GA 30144
HDE NumberH230007
Date Received08/10/2023
Decision Date12/04/2024
Product Code
QSK[ Registered Establishments with QSK ]
Advisory Committee Cardiovascular
Clinical Trials NCT03035643
NCT03397251
NCT05174767
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
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.
Approval OrderApproval Order
SummarySummary of Safety And Probable Benefit
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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