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U.S. Department of Health and Human Services

Product Classification

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Device tissue adhesive, aortic aneurysmorrhaphy
Definition For use as an adjunct in the surgical repair of thoracic aortic aneurysms.
Physical State a two-part liquid that is mixed just prior to use
Technical Method the adhesive is introduced into the false lumen after collapsing the false lumen to minimize the amount of adhesive needing to be dispensed
Target Area false lumen of an aortic aneurysm
Review Panel Cardiovascular
Product CodeODT
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Vascular Surgery Devices Branch (VSDB)
Submission Type HDE - Humanitarian Device Exemption
Device Class HDE
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible