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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Engager Transcatheter Aortic Bioprosthesis; Medtronic CoreValve System
Classification Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
Product Code: NPT
Device Class: 3
Registered Establishment Name: MEDTRONIC IRELAND
Registered Establishment Number: 9612164
Owner/Operator: MEDTRONIC INC.
Owner/Operator Number: 2112641
Establishment Operations: Manufacturer
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