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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Blazer Open Irrigated Ablation Catheter; IntellaTip MiFi Open-Irrigated Ablation Catheter; IntellaTip MiFi Open-Irrigated Cable; Maestro 4000 Controller; Maestro 4000 Pod; Maestro 4000 Remote Control; Metriq Pump
Classification Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
Product Code: OAD
Device Class: 3
Registered Establishment Name: Boston Scientific Corporation
Registered Establishment Number: 3001236349
Owner/Operator: Boston Scientific Corporation
Owner/Operator Number: 9912058
Establishment Operations: U.S. Manufacturer of Export Only Devices
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