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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Ascendra Balloon Aortic Valvuloplasty Catheter; Ascendra Delivery System; Ascendra Introducer Sheath Set; Crimper; Edwards SAPIEN Transcatheter Heart Valve; RetroFlex 3 Delivery System; RetroFlex Balloon Catheter
Classification Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
Product Code: NPT
Device Class: 3
Registered Establishment Name: Edwards Lifesciences LLC
Registered Establishment Number: 3008500478
Owner/Operator: Edwards Lifesciences, LLC.
Owner/Operator Number: 9040666
Establishment Operations: Manufacturer
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