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Establishment Registration & Device Listing

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Product Code : OJX

Establishment
Name

Registration Number

Current
Registration Yr

ST. JUDE MEDICAL OPERATIONS (M) SDN BHD

MALAYSIA

3008494315

2013

drug eluting permanent left ventricular (lv) pacemaker electrode - Unify

Manufacturer

St. Jude Medical Sweden AB

SWEDEN

No number listed

2013

drug eluting permanent left ventricular (lv) pacemaker electrode - Aescula LV Leads, Guidewire, Stylet, Tip Introducer/Torque Tool, Merlin Patient Care System; Atlas DR ICDs, Atlas+ DR ICDs, Atlas+ VR ICDs, Atlas+ HF ICDs, Atlas II+ DR ICDs, Atlas II DR, VR ICDs; Atlas II HF ICDs, Atlas II+HF ICDs, Epic DR ICDs, Epic VR ICDs, Epic+DR ICDs, Epic+ VR ICDs; CRT Leads, Quickflex Left Heart Leads; Current DR, VR ICDs, Promote ICDs, Merlin Antenna; Epic HF ICDs, Epic II DR VR ICDs, Epic II+ DR ICDs, Epic II HF ICDs, Epic+ HF ICDs, Epic II+HF ICDs; Flushing Tool, Merlin@home Transmitter Software, Atlas II+HF ICDs, Durata Active Fixaction Leads; IS4/DF4 Connector Sleeve, IS4/DF4 Plug Accessory Kit, Ellipse DR ICD, Ellipse VR ICD. Fortify Assura ICD; Lead Cap IS-1/DF-1/SJ4, Merlin Patient Care System Software, Programmer Software, Wireless USB Adapter; Merlin Cable Adapter, Merlin "M" Adapter, Merlin Patient System Analyzer, Slit Suture Sleeve,; Merlin Patient Care System Accessories, Slit Suture Sleeve, Stylet Guide, Vein Pick; Merlin@home Transmitter, 3-Lead ECG Cable, Current+ DR VR, ICDs, Promote+ ICDs, Current DR VR ICDs, Promote+ CRT-Ds; Promote CRT-Ds, Riata ST Optim Active Fixation Leads, Stylet Kit, Univerfsal Clip-on Tool; Promote Q CRT-Ds, Promote Quadra CRT-Ds, Quartet Lead, Unify Quadra CRT-D, Wireless Broadband Kit; Quadra Assura CRT-D, Unify Assura CRT-D; QuickFlex Micro Lead, Promote Accel CRT-Ds, Fortify VD DR ICDs, Unify CRT-Ds, Merlin Antenna Adapter

Complaint File Establishment

ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI

CA/USA

2017865

2013

drug eluting permanent left ventricular (lv) pacemaker electrode - Aescula LV Leads, Guidewire, Stylet, Tip Introducer/Torque Tool, Merlin Patient Care System; Atlas DR ICDs, Atlas+ DR ICDs, Atlas+ VR ICDs, Atlas+ HF ICDs, Atlas II+ DR ICDs, Atlas II DR, VR ICDs; Atlas II HF ICDs, Atlas II+HF ICDs, Epic DR ICDs, Epic VR ICDs, Epic+DR ICDs, Epic+ VR ICDs; CRT Leads, Quickflex Left Heart Leads; Current DR, VR ICDs, Promote ICDs, Merlin Antenna; Epic HF ICDs, Epic II DR VR ICDs, Epic II+ DR ICDs, Epic II HF ICDs, Epic+ HF ICDs, Epic II+HF ICDs; Flushing Tool, Merlin@home Transmitter Software, Atlas II+HF ICDs, Durata Active Fixaction Leads; IS4/DF4 Connector Sleeve, IS4/DF4 Plug Accessory Kit, Ellipse DR ICD, Ellipse VR ICD. Fortify Assura ICD; Lead Cap IS-1/DF-1/SJ4, Merlin Patient Care System Software, Programmer Software, Wireless USB Adapter; Merlin Cable Adapter, Merlin "M" Adapter, Merlin Patient System Analyzer, Slit Suture Sleeve,; Merlin Patient Care System Accessories, Slit Suture Sleeve, Stylet Guide, Vein Pick; Merlin@home Transmitter, 3-Lead ECG Cable, Current+ DR VR, ICDs, Promote+ ICDs, Current DR VR ICDs, Promote+ CRT-Ds; Promote CRT-Ds, Riata ST Optim Active Fixation Leads, Stylet Kit, Univerfsal Clip-on Tool; Promote Q CRT-Ds, Promote Quadra CRT-Ds, Quartet Lead, Unify Quadra CRT-D, Wireless Broadband Kit; Quadra Assura CRT-D, Unify Assura CRT-D; QuickFlex Micro Lead, Promote Accel CRT-Ds, Fortify VD DR ICDs, Unify CRT-Ds, Merlin Antenna Adapter

Manufacturer

St. Jude Medical, Cardiac Rhythm Management Division

CA/USA

2938836

2013

drug eluting permanent left ventricular (lv) pacemaker electrode - Aescula LV Leads, Guidewire, Stylet, Tip Introducer/Torque Tool, Merlin Patient Care System; Atlas DR ICDs, Atlas+ DR ICDs, Atlas+ VR ICDs, Atlas+ HF ICDs, Atlas II+ DR ICDs, Atlas II DR, VR ICDs; Atlas II HF ICDs, Atlas II+HF ICDs, Epic DR ICDs, Epic VR ICDs, Epic+DR ICDs, Epic+ VR ICDs; CRT Leads, Quickflex Left Heart Leads; Current DR, VR ICDs, Promote ICDs, Merlin Antenna; Epic HF ICDs, Epic II DR VR ICDs, Epic II+ DR ICDs, Epic II HF ICDs, Epic+ HF ICDs, Epic II+HF ICDs; Flushing Tool, Merlin@home Transmitter Software, Atlas II+HF ICDs, Durata Active Fixaction Leads; IS4/DF4 Connector Sleeve, IS4/DF4 Plug Accessory Kit, Ellipse DR ICD, Ellipse VR ICD. Fortify Assura ICD; Lead Cap IS-1/DF-1/SJ4, Merlin Patient Care System Software, Programmer Software, Wireless USB Adapter; Merlin Cable Adapter, Merlin "M" Adapter, Merlin Patient System Analyzer, Slit Suture Sleeve,; Merlin Patient Care System Accessories, Slit Suture Sleeve, Stylet Guide, Vein Pick; Merlin@home Transmitter, 3-Lead ECG Cable, Current+ DR VR, ICDs, Promote+ ICDs, Current DR VR ICDs, Promote+ CRT-Ds; Promote CRT-Ds, Riata ST Optim Active Fixation Leads, Stylet Kit, Univerfsal Clip-on Tool; Promote Q CRT-Ds, Promote Quadra CRT-Ds, Quartet Lead, Unify Quadra CRT-D, Wireless Broadband Kit; Quadra Assura CRT-D, Unify Assura CRT-D; QuickFlex Micro Lead, Promote Accel CRT-Ds, Fortify VD DR ICDs, Unify CRT-Ds, Merlin Antenna Adapter

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