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Establishment
Name
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Registration Number |
Current
Registration Yr |
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2017865
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2026
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implantable pulse generator, pacemaker (non-crt)
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Avant Models CDHFA700B, CDHFA700D, CDHFA700Q, CDHFA700T; CRT Leads, Quickflex Left Heart Leads; Current DR, VR ICDs, Promote ICDs, Merlin Antenna; Entrant Models - CDHFA300B, CDHFA300D, CDHFA300Q, CDHFA300T; Flushing Tool, Merlin@home Transmitter Software, Durata Active Fixation Leads; Gallant Models - CDHFA500B, CDHFA500D, CDHFA500Q, CDHFA500T; Guidewire, Stylet, Tip Introducer/Torque Tool, Merlin Patient Care System; 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 Patient Care System Software Model 3330 Version 18.1.1; Merlin@home Transmitter, 3-Lead ECG Cable, Current+ DR VR, ICDs, Promote+ ICDs, Current DR VR ICDs, Promote+ CRT-Ds; Neutrino NxT Models - CDHFA600B, CDHFA600D, CDHFA800B, CDHFA800D, CDHFA800Q; Neutrino NxT Models - CDHFA600Q, CDHFA800T, CDHFA600T; Promote CRT-Ds, Stylet Kit,; 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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U.S. Manufacturer of Export Only Devices
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Manufacturer; Complaint File Establishment
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implantable pulse generator, pacemaker (non-crt)
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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
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Specification Developer; Complaint File Establishment
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3006705815
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2026
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implantable pulse generator, pacemaker (non-crt)
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Accent; Sustain XL SC, DC, SR, DR;; Allure RF, Allure Quadra RF, Allure, Allure Quadra, Endurity, Assurity+, and Assurity Family of Pacemakers; Identity ADX, Identity, DC, VDR, Integrity ADx XL, Integrity DR, SR, Verity ADx XL, DR, XL , DC, VDR; Medical Adhesive, Integrity Micro SR DR, ECG Adapter Cable,; Merlin Patient Care System Software Model 3330 Version 18.1.1; Pacing System Analyzer Wand, Victory XL DR, DR, SR; Victory AF DR; Zephyr XL DR, DR, SR;; 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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implantable pulse generator, pacemaker (non-crt)
-
Avant Models CDHFA700B, CDHFA700D, CDHFA700Q, CDHFA700T; CRT Leads, Quickflex Left Heart Leads; Current DR, VR ICDs, Promote ICDs, Merlin Antenna; Entrant Models - CDHFA300B, CDHFA300D, CDHFA300Q, CDHFA300T; Flushing Tool, Merlin@home Transmitter Software, Durata Active Fixation Leads; Gallant Models - CDHFA500B, CDHFA500D, CDHFA500Q, CDHFA500T; Guidewire, Stylet, Tip Introducer/Torque Tool, Merlin Patient Care System; 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 Patient Care System Software Model 3330 Version 18.1.1; Merlin@home Transmitter, 3-Lead ECG Cable, Current+ DR VR, ICDs, Promote+ ICDs, Current DR VR ICDs, Promote+ CRT-Ds; Neutrino NxT Models - CDHFA600B, CDHFA600D, CDHFA800B, CDHFA800D, CDHFA800Q; Neutrino NxT Models - CDHFA600Q, CDHFA800T, CDHFA600T; Promote CRT-Ds, Stylet Kit,; 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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3008494315
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2026
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implantable pulse generator, pacemaker (non-crt)
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Avant Models CDHFA700B, CDHFA700D, CDHFA700Q, CDHFA700T; CRT Leads, Quickflex Left Heart Leads; Current DR, VR ICDs, Promote ICDs, Merlin Antenna; Entrant Models - CDHFA300B, CDHFA300D, CDHFA300Q, CDHFA300T; Flushing Tool, Merlin@home Transmitter Software, Durata Active Fixation Leads; Gallant Models - CDHFA500B, CDHFA500D, CDHFA500Q, CDHFA500T; Guidewire, Stylet, Tip Introducer/Torque Tool, Merlin Patient Care System; 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 Patient Care System Software Model 3330 Version 18.1.1; Merlin@home Transmitter, 3-Lead ECG Cable, Current+ DR VR, ICDs, Promote+ ICDs, Current DR VR ICDs, Promote+ CRT-Ds; Neutrino NxT Models - CDHFA600B, CDHFA600D, CDHFA800B, CDHFA800D, CDHFA800Q; Neutrino NxT Models - CDHFA600Q, CDHFA800T, CDHFA600T; Promote CRT-Ds, Stylet Kit,; 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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implantable pulse generator, pacemaker (non-crt)
-
Accent; Sustain XL SC, DC, SR, DR;; Allure RF, Allure Quadra RF, Allure, Allure Quadra, Endurity, Assurity+, and Assurity Family of Pacemakers; Identity ADX, Identity, DC, VDR, Integrity ADx XL, Integrity DR, SR, Verity ADx XL, DR, XL , DC, VDR; Medical Adhesive, Integrity Micro SR DR, ECG Adapter Cable,; Merlin Patient Care System Software Model 3330 Version 18.1.1; Pacing System Analyzer Wand, Victory XL DR, DR, SR; Victory AF DR; Zephyr XL DR, DR, SR;; 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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3013288201
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2026
|
-
implantable pulse generator, pacemaker (non-crt)
-
Avant Models CDHFA700B, CDHFA700D, CDHFA700Q, CDHFA700T; CRT Leads, Quickflex Left Heart Leads; Current DR, VR ICDs, Promote ICDs, Merlin Antenna; Entrant Models - CDHFA300B, CDHFA300D, CDHFA300Q, CDHFA300T; Flushing Tool, Merlin@home Transmitter Software, Durata Active Fixation Leads; Gallant Models - CDHFA500B, CDHFA500D, CDHFA500Q, CDHFA500T; Guidewire, Stylet, Tip Introducer/Torque Tool, Merlin Patient Care System; 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 Patient Care System Software Model 3330 Version 18.1.1; Merlin@home Transmitter, 3-Lead ECG Cable, Current+ DR VR, ICDs, Promote+ ICDs, Current DR VR ICDs, Promote+ CRT-Ds; Neutrino NxT Models - CDHFA600B, CDHFA600D, CDHFA800B, CDHFA800D, CDHFA800Q; Neutrino NxT Models - CDHFA600Q, CDHFA800T, CDHFA600T; Promote CRT-Ds, Stylet Kit,; 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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Complaint File Establishment
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Complaint File Establishment
|
|
-
implantable pulse generator, pacemaker (non-crt)
-
Accent; Sustain XL SC, DC, SR, DR;; Allure RF, Allure Quadra RF, Allure, Allure Quadra, Endurity, Assurity+, and Assurity Family of Pacemakers; Identity ADX, Identity, DC, VDR, Integrity ADx XL, Integrity DR, SR, Verity ADx XL, DR, XL , DC, VDR; Medical Adhesive, Integrity Micro SR DR, ECG Adapter Cable,; Merlin Patient Care System Software Model 3330 Version 18.1.1; Pacing System Analyzer Wand, Victory XL DR, DR, SR; Victory AF DR; Zephyr XL DR, DR, SR;; 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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3013500228
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2026
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