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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Ascendra + Introducer Sheath Set; Ascendra+ Delivery System; Ascendra+ System; Crimp Stopper; Edwards Crimper; Edwards Dilator Kit; Edwards Expandable Introducer Sheath Set; Edwards SAPIEN XT Transcatheter Heart Valve; NovaFlex + Delivery System; NovaFlex+ System; Qualcrimp crimping accessory
Classification Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
Product Code: NPT
Device Class: 3
Registered Establishment Name: EDWARDS LIFESCIENCES (SINGAPORE) Pte Ltd
Registered Establishment Number: 3007063218
Owner/Operator: Edwards Lifesciences, LLC.
Owner/Operator Number: 9040666
Establishment Operations: Manufacturer
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