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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: FINELINE; FINELINE II; FINELINE II EZ; FINELINE II Sterox; FINELINE II Sterox EZ; Lead Cap Kit; Lead Stabilizer Kit; Straight Stylet; Stylet, Atrial Medium J; Stylet, Large Atrial J Tapered; Stylet, Straight Tapered; Suture Sleeve Accessory Pack; Tapered Stylet; ThinLine; ThinLine EZ; ThinLine II; ThinLine II EZ; ThinLine II Sterox; ThinLine II Sterox EZ
Classification Name: IMPLANTABLE PACEMAKER PULSE-GENERATOR
Product Code: DXY
Device Class: 3
Regulation Number: 870.3610
Medical Specialty: Cardiovascular
Registered Establishment Name: Boston Scientific Corporation
Registered Establishment Number: 2648729
Owner/Operator: Boston Scientific Corporation
Owner/Operator Number: 9912058
Establishment Operations: Manufacturer
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