Establishment Registration & Device Listing

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Establishment
Name

Registration Number

Current
Registration Yr

PRO-TECH DESIGN & MFG., INC.

CA/USA

2032521

2026

implantable pacemaker pulse-generator

Contract Manufacturer

implantable pacemaker pulse-generator

Contract Manufacturer

implantable pacemaker pulse-generator

Contract Manufacturer

implantable pacemaker pulse-generator

Contract Manufacturer

implantable pacemaker pulse-generator

Contract Manufacturer

Sorin CRM SAS

FRANCE

3008159616

2026

implantable pacemaker pulse-generator - Accessory for pacemaker, ICD and CRT-D Permanent magnet; Accessory for pacemaker, ICD and CRT-D Screw driver; ALIZEA DR 1600; ALIZEA SR 1300; CELEA DR 1400; CELEA SR 1100; CPR3 telemetry wand (Accessory to SmartView Hotspot); CPR4BR telemetry wand (Accessory to Smart Spot); Esprit DR; Esprit SR; Reply DR; Reply SR; Smart Spot (Brady home monitor); SmartView Connect App (V1); SMARTVIEW Hotspot Brady Remote Monitoring System

Repackager/Relabeler; Specification Developer; Complaint File Establishment

implantable pacemaker pulse-generator - Accessory for pacemaker, ICD and CRT-D Screw driver; CPR4; Intensia DR 154; Intensia VR 124; Orchestra Plus Programmer; Paradym DR 8550; Paradym RF DR 9550; Paradym RF VR 9250; Paradym VR 8250; PLATINIUM DR 1510; PLATINIUM DR 1540; PLATINIUM VR 1210; PLATINIUM VR 1240; Remote Monitoring Software; Smart Monitor; SmartTouch Programmer Software (SmartView); SMARTVIEW Home Monitor

Repackager/Relabeler; Specification Developer; Complaint File Establishment

implantable pacemaker pulse-generator - Intensia CRT-D 174; ORCHESTRA Plus Link; Paradym CRT-D 8750; Paradym RF CRT-D 9750; PLATINIUM 4LV CRT-D 1744; PLATINIUM CRT-D 1711; PLATINIUM CRT-D 1741; Smart Monitor (Home monitor); SMARTVIEW Home Monitor; SMARTVIEW Hotspot Brady Remote Monitoring System

Repackager/Relabeler; Specification Developer; Complaint File Establishment

St. Jude Medical Coordination Center BVBA European Distribution Center

BELGIUM

3012552532

2026

implantable pacemaker pulse-generator - Avant Models - CDVRA700Q, CDDRA700Q, CDVRA700T, CDDRA700T; Current DR, VR ICD, Merlin Antenna, Promote ICD; DF-1 Receptacle Plug, Hex Wrench,; Entrant Models - CDDRA300Q, CDVRA300T, CDDRA300T; Fortify VR, DR ICD, Wireless Broadband Kit, IS4/DF4 Port Plug Accessory Kit, Ellipse DR, Ellipse VR; Gallant Models - CDVRA500Q, CDDRA500Q, CDVRA500T, CDDRA500T; Integrity ADx XL DR, DR, SR, Verity ADx XL DR, XL DC, XL SR, XL, SC, XL VDR; IS-1 Receptacle Plus, Medical Adhesive; Merlin Live Connect Software Model MLC1000; Merlin Patient Care System Software; Merlin Patient Care System Software Model 3330 Version 18.1.1; Merlin@home Transmitter software, Durata Active Fixation Leads, Lead Cap (IS1/DF1/SJ4; Neutrino NxT Models - CDVRA800Q, CDVRA600Q, CDDRA800Q, CDDRA600Q, CDVRA800T, CDVRA600T, CDDRA800T, CDDRA600T; Programmer Sotware,Merlin@home Tansmitter, Wireless USB Adapter, Current+ DR, VR ICD, Current DR, VR ICD; Promote+ ICD, Promote CRT-D, Promote+ CRT-D, Merlin.net Patient Care Network s/w; Silicone Oil; Stylet Kit, Promote ICD; Vein Pick

Foreign Exporter

St. Jude Medical, Cardiology Division, Inc.

MN/USA

3005334138

2026

implantable pacemaker pulse-generator - Merlin Patient Care System Software Model 3330 Version 18.1.1; Regency family of pacemakers

Complaint File Establishment

Sterigenics Radiation Technologies, LLC

CA/USA

2024024

2026

implantable pacemaker pulse-generator - biologic material, dental Straumann Emdogain 0.7 ml, Multipack

Contract Sterilizer

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Establishment Registration & Device Listing

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