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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Edwards Prima Plus Stentless Bioprosthesis
Classification Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
Product Code: DWE
Device Class: 2
Regulation Number: 870.4390
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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