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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Acticor family; Acticor Sky; BS IS4; CardioMessenger; CardioMessenger Smart 4G; Home Monitoring; ICS 3000; Iforia; Ilesto; Ilivia; Intica; Inventra; Iperia; Itrevia; Lumax; PSW 1502.U; PSW 1503.U; PSW 1506.U; PSW 1507.U; Renamic
Classification Name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Product Code: MRM
Device Class: 3
Registered Establishment Name: BIOTRONIK SE & CO. KG
Registered Establishment Number: 9610139
Premarket Submission Number: P050023
Owner/Operator: BIOTRONIK SE & CO. KG
Owner/Operator Number: 9018331
Establishment Operations: Manufacturer
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