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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Relay NBS Thoracic Stent-Graft with Plus Delivery System; Treovance Abdominal Stent-Graft with Navitel Delivery System
Classification Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Product Code: MIH
Device Class: 3
Registered Establishment Name: BOLTON MEDICAL, INC.
Registered Establishment Number: 2247858
Owner/Operator: BOLTON MEDICAL, INC.
Owner/Operator Number: 9007572
Establishment Operations: Manufacturer; U.S. Manufacturer of Export Only Devices
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