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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: PROMUS Element Plus Monorail Everolimus-Eluting Platinum Chromium Coronary Stent System; PROMUS Element Plus Over the Wire Everolimus-Eluting Platinum Chromium Coronary Stent System; Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail); Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System (Over-the-Wire)
Classification Name: CORONARY DRUG-ELUTING STENT
Product Code: NIQ
Device Class: 3
Registered Establishment Name: BOSTON SCIENTIFIC CORPORATION
Registered Establishment Number: 2134265
Owner/Operator: Boston Scientific Corporation
Owner/Operator Number: 9912058
Establishment Operations: Manufacturer
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