Establishment Registration & Device Listing

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Product Code : NKE

Establishment
Name

Registration Number

Current
Registration Yr

Boston Scientific Corporation

IRELAND

9616693

2013

pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) - CONTAK RENEWAL TR; CONTAK RENEWAL TR Software Application; Externals; INVIVE CRT-P IS-1; INVIVE CRT-P LV-1

Manufacturer

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

MEXICO

3003615065

2013

pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) - Epic? HF System

Contract Manufacturer

pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) - Biotronik ? Atrial Capture Control and Ventricular Pacing Supression

Contract Manufacturer

MEDTRONIC B.V.

NETHERLANDS

3002807561

2013

pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) - INSYNC

Repackager/Relabeler

Medtronic Europe Sàrl

SWITZERLAND

9614453

2013

pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) - Consulta CRT-P; Syncra CRT-P

Manufacturer; Repackager/Relabeler

pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) - Brava; Concerto ICD; Concerto II CRT-D; Consulta DF4 ICD; Consulta ICD; Maximo II CRT-D; Protecta CRT-D; Protecta XT CRT-D; Viva

Manufacturer

pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) - Protecta CRT-D; Protecta XT CRT-D

Manufacturer

pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) - MyCareLink Patient Monitor; Prodigy IPG

Manufacturer

MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS

PR/USA

3004209178

2013

pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) - MyCareLink Patient Monitor; Prodigy IPG

Manufacturer; Repackager/Relabeler

pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) - Attain; Insync

Manufacturer; Repackager/Relabeler

pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) - Protecta CRT-D; Protecta XT CRT-D

Manufacturer; Repackager/Relabeler

pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) - Brava; Concerto ICD; Concerto II CRT-D; Consulta DF4 ICD; Consulta ICD; Maximo II CRT-D; Protecta CRT-D; Protecta XT CRT-D; Viva

Manufacturer

pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) - Brava; Concerto ICD; Concerto II CRT-D; Consulta DF4 ICD; Consulta ICD; Maximo II CRT-D; Protecta CRT-D; Protecta XT CRT-D; Viva

Manufacturer

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Establishment Registration & Device Listing

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