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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: CardioMessenger; Home Monitoring; ICS 3000; Iforia; Iforia DF4; Ilesto; Ilesto DF4; Lumax; PSW 1301.U; Renamic
Classification Name: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
Product Code: NKE
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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