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Establishment Registration & Device Listing

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Product Code : KRG

Establishment
Name

Registration Number

Current
Registration Yr

Boston Scientific Corporation

IRELAND

9616693

2013

programmer, pacemaker - Accessory kit; Antenna Accessory; Bifurcated Bipolar Endocardial Tined Lead; DF-1 Plug; Large Patch Lead; LATITUDE Communicator Inductive; LATITUDE Communicator RF; LATITUDE G2 Communicator; LATITUDE WAVE Communicator; Multiple Application Utility (MAU); Programmer Recorder Monitor (PRM) System Zoom; Small Patch Lead; Software Disk for the VENTAK MINI Pulse Generators; Software Disk for the VENTAK PRx II / III Pulse Generators; Software Disk for the VENTAK PRx Pulse Generators; VENTAK MINI; VENTAK MINI HE; VENTAK MINI II; VENTAK MINI III; VENTAK MINI III HE; VENTAK MINI IV; VENTAK PRx II; VENTAK PRx III; ZOOM LATITUDE Programmer/Recorder/Monitor

Manufacturer

programmer, pacemaker - DISCOVERY DR; DISCOVERY SR; MERIDIAN DDD; MERIDIAN DR; MERIDIAN SR; MERIDIAN SSI; Patient Test Magnet; PDF Report Generator; Programmer Recorder Monitor (PRM) System ZOOM; VIGOR DR; VIGOR Software Module; VIGOR SR

Manufacturer

programmer, pacemaker - DELTA; DELTA T; DELTA TRS; DELTA/VISTA Software Module; Paper Roll; Programmer Recorder Monitor (PRM) System ZOOM; Telemetry Wand; VIGOR DDD; VIGOR Software Module; VIGOR SSI; VISTA; VISTA 6; VISTA DDD; VISTA T

Manufacturer

programmer, pacemaker - CONFIENT RF1 HE IS-1; CONFIENT RF1 HE IS-1 AV; Diagnostic Restoration Tool for PRIZM DR/HE and PRIZM VR/HE; ENERGEN DR DF1; ENERGEN DR IS4; ENERGEN VR DF1; ENERGEN VR IS4; INCEPTA VR IS4; LATITUDE Communicator Inductive; LATITUDE G2 Communicator; Programmer Recorder Monitor (PRM) System ZOOM; Programmer Software Application; PUNCTUA DR DF1; PUNCTUA DR IS4; PUNCTUA VR DF1; PUNCTUA VR IS4; Quick Profiles Disk; TELIGEN HE DR DF1; TELIGEN HE DR IS4; TELIGEN HE VR DF1; TELIGEN HE VR IS4; VENTAK AV; VENTAK AV II DDD; VENTAK AV II DR; VENTAK AV III DR; VENTAK PRIZM VR/DR; VENTAK VR; VITALITY 2 DR / DR EL; VITALITY 2 VR / VR EL; VITALITY DR; VITALITY DS; VITALITY DS/VR; VITALITY HE; VITALITY VR; VITALITY+ DR

Manufacturer

Jabil Circuit (Shanghai), LTD.

CHINA

3005210579

2013

programmer, pacemaker - LATITUDE Wave Communicator

Contract Manufacturer

MAQUILAS TETA KAWI S.A. DE C.V., DEPARTMENTO: PREC

MEXICO

3003615065

2013

programmer, pacemaker - Biotronik ? Atrial Capture Control and Ventricular Pacing Supression

Contract Manufacturer

Medtronic Europe Sàrl

SWITZERLAND

9614453

2013

programmer, pacemaker - Prodigy IPG

Manufacturer

MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS

PR/USA

3004209178

2013

programmer, pacemaker - Prodigy IPG

Manufacturer; Repackager/Relabeler

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