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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: CONFIENT RF1 HE IS-1; CONFIENT RF1 HE IS-1 AV; Diagnostic Restoration Tool for PRIZM DR/HE and PRIZM VR/HE; ENERGEN DR DF1; ENERGEN DR IS4; ENERGEN VR DF1; ENERGEN VR IS4; INCEPTA VR IS4; LATITUDE Communicator Inductive; LATITUDE G2 Communicator; Programmer Recorder Monitor (PRM) System ZOOM; Programmer Software Application; PUNCTUA DR DF1; PUNCTUA DR IS4; PUNCTUA VR DF1; PUNCTUA VR IS4; Quick Profiles Disk; TELIGEN HE DR DF1; TELIGEN HE DR IS4; TELIGEN HE VR DF1; TELIGEN HE VR IS4; VENTAK AV; VENTAK AV II DDD; VENTAK AV II DR; VENTAK AV III DR; VENTAK PRIZM VR/DR; VENTAK VR; VITALITY 2 DR / DR EL; VITALITY 2 VR / VR EL; VITALITY DR; VITALITY DS; VITALITY DS/VR; VITALITY HE; VITALITY VR; VITALITY+ DR
Classification Name: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
Product Code: LWP
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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