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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Accessory for pacemaker, ICD and CRT-D Screw driver; Defibrillator implantable dual chamber Paradym DR 8550; Defibrillator implantable dual chamber Paradym RF DR 9550; Defibrillator implantable dual chamber Paradym RF VR 9250; Defibrillator implantable single chamber Paradym VR 8250
Classification Name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Product Code: MRM
Device Class: 3
Registered Establishment Name: Sorin CRM SAS
Registered Establishment Number: 3008159616
Owner/Operator: Sorin CRM USA, Inc.
Owner/Operator Number: 2182863
Establishment Operations: Repackager/Relabeler; Specification Developer; Complaint File Establishment
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