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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: ATS Open Pivot Bi-leaflet ; MHV ATS Open Pivot Aortic Valved Graft
Classification Name: HEART-VALVE, MECHANICAL
Product Code: LWQ
Device Class: 3
Registered Establishment Name: MEDTRONIC, INC.
Registered Establishment Number: 2182208
Owner/Operator: MEDTRONIC INC.
Owner/Operator Number: 2112641
Establishment Operations: Specification Developer