Establishment Registration & Device Listing

Proprietary Name:	ACUITY Spiral; ACUITY X4 Flushing Tool/Wire Guide; ACUITY X4 Spiral; ACUITY X4 Straight; AUTOGEN CRT-D; AUTOGEN X4 CRT-D; Bi Directional Torque Wrench; CONTAK CD Software Application; CONTAK CD2 Software Application; CONTAK RENEWAL AVT Software; CONTAK RENEWAL Software Application; DYNAGEN CRT-D; DYNAGEN X4 CRT-D; EASYTRAK 2; EASYTRAK 2 IS-1; EASYTRAK 3; EASYTRAK 3 IS-1; ENERGEN CRT-D; INCEPTA CRT-D; INOGEN CRT-D; INOGEN X4 CRT-D; Lead Cap; MOMENTUM CRT-D; MOMENTUM X4 CRT-D; PUNCTUA CRT-D; RESONATE CRT-D; RESONATE HF CRT-D; RESONATE X4 CRT-D; Suture Sleeve; VIGILIANT CRT-D; VIGILIANT X4 CRT-D
Classification Name:	DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATION (CRT-D)
Product Code:	NIK
Device Class:	3
Registered Establishment Name:	Boston Scientific Limited
Registered Establishment Number:	9616693
Premarket Submission Number:	P010012
Owner/Operator:	Boston Scientific Corporation
Owner/Operator Number:	9912058
Establishment Operations:	Manufacturer