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Establishment
Name
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Registration Number |
Current
Registration Yr |
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3008494315
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2013
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No number listed
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2013
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pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
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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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Complaint File Establishment
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Complaint File Establishment
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pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
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Accent; Sustain XL SC, DC, SR, DR;; Identity ADX, Identity, DC, VDR, Integrity ADx XL, Integrity DR, SR, Verity ADx XL, DR, XL , DC, VDR; Medical Adhesive, Integrity Micro SR DR, Identity DR, XL, DR, SR;Atlas DR, VR ICD, ECG Adapter Cable,; Pacing System Analyzer Wand, Victory XL DR, DR, SR; Victory AF DR; Zephyr XL DR, DR, SR;; Solus II, Syncrony III, Trilogy DR+, APS Micro Programmer, Advent AV Plus DX Lead, Trilogy SR+; Syncrony II, Solas, Paragon III, Phoenix III Pacemakers; Trilogy DC+. Polarity, Affinity DR SR DC, Programmer, entity DR DC, Integrity SR, AFx DR, Afinity VDR; Zephyr XL SR; Accent SR, SR RF, DR, DR RF; Anthem CRT-P, RF CRT-P; Sustain XL, DC/SC; Sustain DR/SR
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Complaint File Establishment
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pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
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Accessory Kit, Adapter Block 4x8, Auxiliary Cable, Battery Charger, Defibrillation Lead Cap, Defibrillator Lead Adapter; Angstrom MD, Contour MD, Profile II, Profile MD, Profile Test Can, DF-1 Receptacle Plug, Hex Wrench,; Atlas DR ICD, Atlas+ DR ICD, Atlas+ VR ICD, Atlas+ HF ICD, Atlas II+ DR ICD, Atlas II DR, VR ICD; Atlas DR, VR ICD, ECG Adapter Cable, Identity ADx DR, XL DR, Identity ADx XL DC, SR, ADx VDR; Atlas II HF ICD, Atlas II+HF ICD, Epic DR ICD, Epic VR ICD, Epic+ DR ICD, Epic+ VR ICD, Epic HF ICD, Epic II DR VR; Dual chamber Isolated Output Cable, Vein Pick, Housecall Transtelephonic Receiver and Transmitter; Epic II+ DR, Epic II HF ICD, Epic+ HF ICD, Epic II+ Hf ICD, Merlin Patient Care system Software; Fortify VR, DR ICD, Wireless Broadband Kit, IS4/DF4 Port Plug Accessory Kit, Ellipse DR, Ellipse VR; Housecall Plus Transtelephonic Monitoring System; Housecall Plus Transtelephonic Monitoring System (Merlin.net), Current DR, VR ICD, Merlin Antenna, Promote ICD; HVS-02, Magnet, Monitoring Lead sets, Patient Cable, Silicone Oil, Test Lead, Torque Driver, VS-1 Adapter for HVS; Integrity ADx XL DR, DR, SR, Verity ADx XL DR, XL DC, XL SR, XL, SC, XL VDR; IS-1 Receptacle Plus, Photon DR ICD, Medical Adhesive, Photon Micro DR VR ICD, Identity DDR, XL DR, SR; Merlin@home Transmitter software, Atlas II+ ICD, Drata Active Fixation Leads, Lead Cap (IS1/DF1/SJ4; PR-1500 Isolated Output, Programmer, Programmer Wand, Wand Adapter, Defibrillator Patch Lead; Programmer Sotware,Merlin@home Tansmitter, Wireless USB Adapter, Current+ DR, VR ICD, Current DR, VR ICD; Promote+ ICD, Promote CRT-D, Promote+ CRT-D, Crrent Accel VR DDR, Merlin.net Patient Care Network s/w; Stylet Kit, Promote ICD, Riata ST Optim Active fixation Leads, Univerrsal ClipOn Tool,; Test Cable, Test Can, ECG Cable, 4-Channel Output Cable, Lead Insertion Tool, Angstrom II, Contour II, Software,
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Complaint File Establishment
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2017865
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2013
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pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
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Accessory Kit, Adapter Block 4x8, Auxiliary Cable, Battery Charger, Defibrillation Lead Cap, Defibrillator Lead Adapter; Angstrom MD, Contour MD, Profile II, Profile MD, Profile Test Can, DF-1 Receptacle Plug, Hex Wrench,; Atlas DR ICD, Atlas+ DR ICD, Atlas+ VR ICD, Atlas+ HF ICD, Atlas II+ DR ICD, Atlas II DR, VR ICD; Atlas DR, VR ICD, ECG Adapter Cable, Identity ADx DR, XL DR, Identity ADx XL DC, SR, ADx VDR; Atlas II HF ICD, Atlas II+HF ICD, Epic DR ICD, Epic VR ICD, Epic+ DR ICD, Epic+ VR ICD, Epic HF ICD, Epic II DR VR; Dual chamber Isolated Output Cable, Vein Pick, Housecall Transtelephonic Receiver and Transmitter; Epic II+ DR, Epic II HF ICD, Epic+ HF ICD, Epic II+ Hf ICD, Merlin Patient Care system Software; Fortify VR, DR ICD, Wireless Broadband Kit, IS4/DF4 Port Plug Accessory Kit, Ellipse DR, Ellipse VR; Housecall Plus Transtelephonic Monitoring System; Housecall Plus Transtelephonic Monitoring System (Merlin.net), Current DR, VR ICD, Merlin Antenna, Promote ICD; HVS-02, Magnet, Monitoring Lead sets, Patient Cable, Silicone Oil, Test Lead, Torque Driver, VS-1 Adapter for HVS; Integrity ADx XL DR, DR, SR, Verity ADx XL DR, XL DC, XL SR, XL, SC, XL VDR; IS-1 Receptacle Plus, Photon DR ICD, Medical Adhesive, Photon Micro DR VR ICD, Identity DDR, XL DR, SR; Merlin@home Transmitter software, Atlas II+ ICD, Drata Active Fixation Leads, Lead Cap (IS1/DF1/SJ4; PR-1500 Isolated Output, Programmer, Programmer Wand, Wand Adapter, Defibrillator Patch Lead; Programmer Sotware,Merlin@home Tansmitter, Wireless USB Adapter, Current+ DR, VR ICD, Current DR, VR ICD; Promote+ ICD, Promote CRT-D, Promote+ CRT-D, Crrent Accel VR DDR, Merlin.net Patient Care Network s/w; Stylet Kit, Promote ICD, Riata ST Optim Active fixation Leads, Univerrsal ClipOn Tool,; Test Cable, Test Can, ECG Cable, 4-Channel Output Cable, Lead Insertion Tool, Angstrom II, Contour II, Software,
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pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
-
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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pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
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Accent; Sustain XL SC, DC, SR, DR;; Identity ADX, Identity, DC, VDR, Integrity ADx XL, Integrity DR, SR, Verity ADx XL, DR, XL , DC, VDR; Medical Adhesive, Integrity Micro SR DR, Identity DR, XL, DR, SR;Atlas DR, VR ICD, ECG Adapter Cable,; Pacing System Analyzer Wand, Victory XL DR, DR, SR; Victory AF DR; Zephyr XL DR, DR, SR;; Solus II, Syncrony III, Trilogy DR+, APS Micro Programmer, Advent AV Plus DX Lead, Trilogy SR+; Syncrony II, Solas, Paragon III, Phoenix III Pacemakers; Trilogy DC+. Polarity, Affinity DR SR DC, Programmer, entity DR DC, Integrity SR, AFx DR, Afinity VDR; Zephyr XL SR; Accent SR, SR RF, DR, DR RF; Anthem CRT-P, RF CRT-P; Sustain XL, DC/SC; Sustain DR/SR
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2938836
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2013
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-
pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
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Accessory Kit, Adapter Block 4x8, Auxiliary Cable, Battery Charger, Defibrillation Lead Cap, Defibrillator Lead Adapter; Angstrom MD, Contour MD, Profile II, Profile MD, Profile Test Can, DF-1 Receptacle Plug, Hex Wrench,; Atlas DR ICD, Atlas+ DR ICD, Atlas+ VR ICD, Atlas+ HF ICD, Atlas II+ DR ICD, Atlas II DR, VR ICD; Atlas DR, VR ICD, ECG Adapter Cable, Identity ADx DR, XL DR, Identity ADx XL DC, SR, ADx VDR; Atlas II HF ICD, Atlas II+HF ICD, Epic DR ICD, Epic VR ICD, Epic+ DR ICD, Epic+ VR ICD, Epic HF ICD, Epic II DR VR; Dual chamber Isolated Output Cable, Vein Pick, Housecall Transtelephonic Receiver and Transmitter; Epic II+ DR, Epic II HF ICD, Epic+ HF ICD, Epic II+ Hf ICD, Merlin Patient Care system Software; Fortify VR, DR ICD, Wireless Broadband Kit, IS4/DF4 Port Plug Accessory Kit, Ellipse DR, Ellipse VR; Housecall Plus Transtelephonic Monitoring System; Housecall Plus Transtelephonic Monitoring System (Merlin.net), Current DR, VR ICD, Merlin Antenna, Promote ICD; HVS-02, Magnet, Monitoring Lead sets, Patient Cable, Silicone Oil, Test Lead, Torque Driver, VS-1 Adapter for HVS; Integrity ADx XL DR, DR, SR, Verity ADx XL DR, XL DC, XL SR, XL, SC, XL VDR; IS-1 Receptacle Plus, Photon DR ICD, Medical Adhesive, Photon Micro DR VR ICD, Identity DDR, XL DR, SR; Merlin@home Transmitter software, Atlas II+ ICD, Drata Active Fixation Leads, Lead Cap (IS1/DF1/SJ4; PR-1500 Isolated Output, Programmer, Programmer Wand, Wand Adapter, Defibrillator Patch Lead; Programmer Sotware,Merlin@home Tansmitter, Wireless USB Adapter, Current+ DR, VR ICD, Current DR, VR ICD; Promote+ ICD, Promote CRT-D, Promote+ CRT-D, Crrent Accel VR DDR, Merlin.net Patient Care Network s/w; Stylet Kit, Promote ICD, Riata ST Optim Active fixation Leads, Univerrsal ClipOn Tool,; Test Cable, Test Can, ECG Cable, 4-Channel Output Cable, Lead Insertion Tool, Angstrom II, Contour II, Software,
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Complaint File Establishment
|
|
-
pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
-
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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Complaint File Establishment
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pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
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Accent; Sustain XL SC, DC, SR, DR;; Identity ADX, Identity, DC, VDR, Integrity ADx XL, Integrity DR, SR, Verity ADx XL, DR, XL , DC, VDR; Medical Adhesive, Integrity Micro SR DR, Identity DR, XL, DR, SR;Atlas DR, VR ICD, ECG Adapter Cable,; Pacing System Analyzer Wand, Victory XL DR, DR, SR; Victory AF DR; Zephyr XL DR, DR, SR;; Solus II, Syncrony III, Trilogy DR+, APS Micro Programmer, Advent AV Plus DX Lead, Trilogy SR+; Syncrony II, Solas, Paragon III, Phoenix III Pacemakers; Trilogy DC+. Polarity, Affinity DR SR DC, Programmer, entity DR DC, Integrity SR, AFx DR, Afinity VDR; Zephyr XL SR; Accent SR, SR RF, DR, DR RF; Anthem CRT-P, RF CRT-P; Sustain XL, DC/SC; Sustain DR/SR
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Complaint File Establishment
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3006705815
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2013
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-
pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
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Accent; Sustain XL SC, DC, SR, DR;; Identity ADX, Identity, DC, VDR, Integrity ADx XL, Integrity DR, SR, Verity ADx XL, DR, XL , DC, VDR; Medical Adhesive, Integrity Micro SR DR, Identity DR, XL, DR, SR;Atlas DR, VR ICD, ECG Adapter Cable,; Pacing System Analyzer Wand, Victory XL DR, DR, SR; Victory AF DR; Zephyr XL DR, DR, SR;; Solus II, Syncrony III, Trilogy DR+, APS Micro Programmer, Advent AV Plus DX Lead, Trilogy SR+; Syncrony II, Solas, Paragon III, Phoenix III Pacemakers; Trilogy DC+. Polarity, Affinity DR SR DC, Programmer, entity DR DC, Integrity SR, AFx DR, Afinity VDR; Zephyr XL SR; Accent SR, SR RF, DR, DR RF; Anthem CRT-P, RF CRT-P; Sustain XL, DC/SC; Sustain DR/SR
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pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
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Accessory Kit, Adapter Block 4x8, Auxiliary Cable, Battery Charger, Defibrillation Lead Cap, Defibrillator Lead Adapter; Angstrom MD, Contour MD, Profile II, Profile MD, Profile Test Can, DF-1 Receptacle Plug, Hex Wrench,; Atlas DR ICD, Atlas+ DR ICD, Atlas+ VR ICD, Atlas+ HF ICD, Atlas II+ DR ICD, Atlas II DR, VR ICD; Atlas DR, VR ICD, ECG Adapter Cable, Identity ADx DR, XL DR, Identity ADx XL DC, SR, ADx VDR; Atlas II HF ICD, Atlas II+HF ICD, Epic DR ICD, Epic VR ICD, Epic+ DR ICD, Epic+ VR ICD, Epic HF ICD, Epic II DR VR; Dual chamber Isolated Output Cable, Vein Pick, Housecall Transtelephonic Receiver and Transmitter; Epic II+ DR, Epic II HF ICD, Epic+ HF ICD, Epic II+ Hf ICD, Merlin Patient Care system Software; Fortify VR, DR ICD, Wireless Broadband Kit, IS4/DF4 Port Plug Accessory Kit, Ellipse DR, Ellipse VR; Housecall Plus Transtelephonic Monitoring System; Housecall Plus Transtelephonic Monitoring System (Merlin.net), Current DR, VR ICD, Merlin Antenna, Promote ICD; HVS-02, Magnet, Monitoring Lead sets, Patient Cable, Silicone Oil, Test Lead, Torque Driver, VS-1 Adapter for HVS; Integrity ADx XL DR, DR, SR, Verity ADx XL DR, XL DC, XL SR, XL, SC, XL VDR; IS-1 Receptacle Plus, Photon DR ICD, Medical Adhesive, Photon Micro DR VR ICD, Identity DDR, XL DR, SR; Merlin@home Transmitter software, Atlas II+ ICD, Drata Active Fixation Leads, Lead Cap (IS1/DF1/SJ4; PR-1500 Isolated Output, Programmer, Programmer Wand, Wand Adapter, Defibrillator Patch Lead; Programmer Sotware,Merlin@home Tansmitter, Wireless USB Adapter, Current+ DR, VR ICD, Current DR, VR ICD; Promote+ ICD, Promote CRT-D, Promote+ CRT-D, Crrent Accel VR DDR, Merlin.net Patient Care Network s/w; Stylet Kit, Promote ICD, Riata ST Optim Active fixation Leads, Univerrsal ClipOn Tool,; Test Cable, Test Can, ECG Cable, 4-Channel Output Cable, Lead Insertion Tool, Angstrom II, Contour II, Software,
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