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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: ICS 3000; PSW 1203.U/1; Renamic
Classification Name: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
Product Code: NKE
Device Class: 3
Registered Establishment Name: BIOTRONIK SE & CO. KG
Registered Establishment Number: 9610139
Owner/Operator: BIOTRONIK SE & CO. KG
Owner/Operator Number: 9018331
Establishment Operations: Manufacturer
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