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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Dextrus; EDP; Effecta; Estella; Evia; ICS 3000; Model 3145; Model 3150; Model 3171; Model 3175; Model 6646; Model 6652; Model 6653; P-KIT; Reliaty; Renamic; Reocor; Selox; Setrox S; Solia CSP S 53; Solia CSP S 60; Solia JT 45; Solia JT 53; Solia S 45; Solia S 53; Solia S 60; Solia T 53; Solia T 60; Tilda
Classification Name: PERMANENT PACEMAKER ELECTRODE
Product Code: DTB
Device Class: 3
Regulation Number: 870.3680
Medical Specialty: Cardiovascular
Registered Establishment Name: BIOTRONIK SE & CO. KG
Registered Establishment Number: 9610139
Premarket Submission Number: P950037
Owner/Operator: BIOTRONIK SE & CO. KG
Owner/Operator Number: 9018331
Establishment Operations: Manufacturer
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