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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Frontier, Frontier II, Anthem Family of CRT-PS; Merlin Patient Care System Software Model 3330 Version 18.1.1; MerlinConduct Mobile Software Application Model 3330 Version 16.1
Classification Name: PULSE-GENERATOR, SINGLE CHAMBER, SENSOR DRIVEN, IMPLANTABLE
Product Code: LWO
Device Class: 3
Registered Establishment Name: ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISION
Registered Establishment Number: 2017865
Owner/Operator: St. Jude Medical, Inc.
Owner/Operator Number: 2126673
Establishment Operations: Manufacturer
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