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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: DELTA; DELTA T; DELTA TRS; DELTA/VISTA Software Module; Paper Roll; Programmer Recorder Monitor (PRM) System ZOOM; Telemetry Wand; VIGOR DDD; VIGOR Software Module; VIGOR SSI; VISTA; VISTA 6; VISTA DDD; VISTA T
Classification Name: PROGRAMMER, PACEMAKER
Product Code: KRG
Device Class: 3
Regulation Number: 870.3700
Medical Specialty: Cardiovascular
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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