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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; Edora; Enitra; Enticos; Entovis HF(-T); Evia HF(-T); Evity; Home Monitoring; ICS 3000; LV-KIT; PSW 1301.U; Renamic; Sentus OTW QP L/S; Stratos
Classification Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
Product Code: NVZ
Device Class: 3
Registered Establishment Name: BIOTRONIK, INC.
Registered Establishment Number: 1028232
Premarket Submission Number: P070008
Owner/Operator: BIOTRONIK, INC.
Owner/Operator Number: 1028232
Establishment Operations: Repackager/Relabeler
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