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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: BS IS-1 Blind Plug; CardioMessenger; Dextrus; DH; Ecuro; EDP; Effecta; EFH; Entovis; Estella; Evia; Home Monitoring; ICS 3000; Model 3145; Model 3150; Model 3171; Model 3175; Model 6646; Model 6652; Model 6653; NK-29; P-KIT; PK-155; PK-175; PK-222; PK-83; PSW 1301.U; PSW 1307.U; Reliaty; Renamic; Reocor; S 45; S 53; S 58; S 60; Selox; Setrox S; Solox; Tilda
Classification Name: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELECTRODES
Product Code: NVN
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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