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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: ACUITY Spiral; Bi Directional Torque Wrench; COGNIS; CONTAK CD; CONTAK CD Software Application; CONTAK CD2; CONTAK CD2 Software Application; CONTAK RENEWAL 3; CONTAK RENEWAL 3 AVT; CONTAK RENEWAL 3 AVT HE; CONTAK RENEWAL 3 HE; CONTAK RENEWAL 3 RF; CONTAK RENEWAL 3 RF HE; CONTAK RENEWAL AVT Software; CONTAK RENEWAL Software Application; DYNAGEN CRT-D; DYNAGEN X4 CRT-D; EASYTRAK; EASYTRAK 2; EASYTRAK 2 IS-1; EASYTRAK 3; EASYTRAK 3 IS-1; ENERGEN CRT-D DF1/IS1; ENERGEN CRT-D IS4; Externals; Finishing Wire; INCEPTA CRT-D DF1/IS1; INCEPTA CRT-D DF1/LV1; INCEPTA CRT-D IS4; INOGEN CRT-D; INOGEN X4 CRT-D; Lead Cap; Lead Stability Accessory (Suture Sleeve); LIVIAN RF1 HE; LIVIAN RF1 SE; ORIGEN CRT-D; ORIGEN X4 CRT-D; PUNCTUA CRT-D DF1/IS1; PUNCTUA CRT-D IS4; Suture Sleeve
Classification Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATION (CRT-D)
Product Code: NIK
Device Class: 3
Registered Establishment Name: Boston Scientific Corporation
Registered Establishment Number: 9616693
Owner/Operator: Boston Scientific Corporation
Owner/Operator Number: 9912058
Establishment Operations: Manufacturer
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