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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: CardioMessenger; Celerity; Corox; Entovis HF(-T); Evia HF(-T); Home Monitoring; ICS 3000; LV-KIT; PSW 1203.U/1; Renamic; Stratos
Classification Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
Product Code: LWS
Device Class: 3
Registered Establishment Name: BIOTRONIK, INC.
Registered Establishment Number: 1028232
Owner/Operator: BIOTRONIK, INC.
Owner/Operator Number: 1028232
Establishment Operations: Repackager/Relabeler
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