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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Carpentier-Edwards Bioprosthesis; Carpentier-Edwards Bioprosthetic Valved Conduit
Classification Name: REPLACEMENT HEART-VALVE
Product Code: DYE
Device Class: 3
Regulation Number: 870.3925
Medical Specialty: Cardiovascular
Registered Establishment Name: Edwards Lifescience AG
Registered Establishment Number: 9614464
Owner/Operator: Edwards Lifesciences, LLC.
Owner/Operator Number: 9040666
Establishment Operations: Manufacturer
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