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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Lotus Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System
Classification Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
Product Code: NPT
Device Class: 3
Registered Establishment Name: BOSTON SCIENTIFIC CORPORATION
Registered Establishment Number: 3003882783
Owner/Operator: Boston Scientific Corporation
Owner/Operator Number: 9912058
Establishment Operations: U.S. Manufacturer of Export Only Devices
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