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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Fortevo AAA Endograft with Heli-FX EndoAnchor System
Classification Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Product Code: MIH
Device Class: 3
Registered Establishment Name: APTUS ENDOSYSTEMS
Registered Establishment Number: 3008493192
Owner/Operator: Aptus Endosystems
Owner/Operator Number: 10033180
Establishment Operations: U.S. Manufacturer of Export Only Devices
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