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PDF 

MRI-Ready IDE Study Clinical Summary

[PDF 0.88MB] (EN)

CDHFA600Q Neutrino NxTHF_ICD_JMRI_US, CDHFA800Q Neutrino NxTHF_ICD_JMRI_US, CDVRA700Q Avant VR_ICD_UMRI_US, CDDRA700Q Avant DR_ICD_UMRI_US, CDHFA700Q Avan More
100170659, 100168215, 100167396, 100167384, 100168022, 100167398, 100167399, 100168025, 100167340, 100167380, 100167451, 100170626, 100168192, 1001706 More
ARTEN600131576 - A
Effective Begin Date 9/4/2020
Effective End Date
RevisionType:
View all previous versions To request a previous version, contact Customer Service: customerservice@sjm.com, 855-4ST-JUDE (855-478-5833)

Changes to manuals that are designated as "safety" were made to address safety issues.

MRI-Ready IDE Study Clinical Summary

Products, 15 Total

  • CDHFA600Q Neutrino NxTHF_ICD_JMRI_US
  • CDHFA800Q Neutrino NxTHF_ICD_JMRI_US
  • CDVRA700Q Avant VR_ICD_UMRI_US
  • CDDRA700Q Avant DR_ICD_UMRI_US
  • CDHFA700Q Avant HF_ICD_BMRI_US
  • CDVRA500Q Gallant VR_ICD_UMRI_US
  • CDDRA500Q Gallant DR_ICD_UMRI_US
  • CDHFA500Q Gallant HF_ICD_BMRI_US
  • CDVRA300Q Entrant VR_ICD_UMRI_US
  • CDDRA300Q Entrant DR_ICD_UMRI_US
  • CDHFA300Q Entrant HF_ICD_OMRI_US
  • CDVRA600Q Neutrino NxTVR_ICD_JMRI_US
  • CDVRA800Q Neutrino NxTVR_ICD_JMRI_US
  • CDDRA600Q Neutrino NxTDR_ICD_JMRI_US
  • CDDRA800Q NeutrinoNxT DR_ICD_JMRI_US
See All

MRI-Ready IDE Study Clinical Summary

Reorder/Model Numbers, 15 Total

  • 100170659
  • 100168215
  • 100167396
  • 100167384
  • 100168022
  • 100167398
  • 100167399
  • 100168025
  • 100167340
  • 100167380
  • 100167451
  • 100170626
  • 100168192
  • 100170675
  • 100167329
See All

PDF MRI Ready Monitor Systems Manual for Jot Dx ICM Model DM4500; US [PDF 0.15MB] (EN)

DM4500 Jot Dx_ICM_UMRI_US (ICM 1.7) More
600179836 More
ARTEN600180897 - A
Effective Begin Date 6/11/2021
Effective End Date
RevisionType:
View all previous versions To request a previous version, contact Customer Service: customerservice@sjm.com, 855-4ST-JUDE (855-478-5833)

Changes to manuals that are designated as "safety" were made to address safety issues.

MRI Ready Monitor Systems Manual for Jot Dx ICM Model DM4500; US

Products, 1 Total

  • DM4500 Jot Dx_ICM_UMRI_US (ICM 1.7)
See All

MRI Ready Monitor Systems Manual for Jot Dx ICM Model DM4500; US

Reorder/Model Numbers, 1 Total

  • 600179836
See All

PDF MRI-Ready Systems Manual
MRI Procedure Information for the Abbott Medical MR Conditional System [PDF 3.55MB] (EN)

7120Q/58 DURATA LEAD, 7120Q/65 DURATA LEAD, 7122Q/58 DURATA LEAD, 7122Q/65 DURATA LEAD, LPA1200M/52 Tendril MRI Lead, LPA1200M/58 Tendril MRI Lead, LPA1200M More
100016969, 100016970, 100016975, 100016976, 100048215, 100048252, 100048895, 100057803, 100057835, 100075173, 100080105, 100080180, 100080244, 1000802 More
ARTEN600186361 - B
Effective Begin Date 9/14/2021
Effective End Date
RevisionType:
View all previous versions To request a previous version, contact Customer Service: customerservice@sjm.com, 855-4ST-JUDE (855-478-5833)

Changes to manuals that are designated as "safety" were made to address safety issues.

MRI-Ready Systems Manual
MRI Procedure Information for the Abbott Medical MR Conditional System

Products, 40 Total

  • 7120Q/58 DURATA LEAD
  • 7120Q/65 DURATA LEAD
  • 7122Q/58 DURATA LEAD
  • 7122Q/65 DURATA LEAD
  • LPA1200M/52 Tendril MRI Lead
  • LPA1200M/58 Tendril MRI Lead
  • LPA1200M/46 Tendril MRILead
  • CD1311-36Q Ellipse VRICD_U_US
  • CD2311-36Q Ellipse DRICD_U_US
  • LDA210Q/58 OPTISURELEAD SS_U_US
  • CD2411-36QC EllipseDR_ICD_U_US
  • CD2411-36Q EllipseDR_ICD_U_US
  • CD1411-36Q EllipseVR_ICD_U_US
  • CD1411-36QC EllipseVR_ICD_U_US
  • PM2172 Endurity MRI_Pacemaker_U_US
  • PM2272 Assurity MRI_Pacemaker_U_US
  • CD3365-40QC QuadraAssura_ICD_UMRI_US
  • CD3369-40Q QuadraAssura MP_ICD_UMRI_US
  • CD3369-40QC QuadraAssura MP_ICD_UMRI_US
  • LDA210Q/65 OPTISURE LEADSS_U_US
  • PM1224 Accent MRIPacemaker_B_US
  • PM2218 Accent MRIDR RF Pacemaker_U_US
  • 2088TC/46 TENDRIL STS LEAD
  • 2088TC/52 TENDRIL STS LEAD
  • 2088TC/58 Domestic
See All

MRI-Ready Systems Manual
MRI Procedure Information for the Abbott Medical MR Conditional System

Reorder/Model Numbers, 40 Total

  • 100016969
  • 100016970
  • 100016975
  • 100016976
  • 100048215
  • 100048252
  • 100048895
  • 100057803
  • 100057835
  • 100075173
  • 100080105
  • 100080180
  • 100080244
  • 100080272
  • 100108355
  • 100108427
  • 100080437
  • 100080439
  • 100080449
  • 100075174
  • 100027906
  • 100128344
  • 100015306
  • 100015307
  • 100015504
See All

PDF 

MRI-Ready Systems Manual
MRI Procedure Information for the Abbott Medical
MR Conditional System

[PDF 1.02MB] (EN)

CDVRA700Q Avant VR_ICD_UMRI_PR, CDVRA800Q NeutrinoNxT VR_ICD_JMRI_PR, CDVRA600Q Neutrino NxTVR_ICD_JMRI_PR, CDVRA500Q Gallant VR_ICD_BMRI_PR, CDVRA300Q En More
100167336, 100167457, 100170598, 100167386, 100167461, 100167326, 100167443, 100170628, 100167407, 100167390, 100167337, 100167444, 100170670, 1001673 More
ARTEN600180017 - A
Effective Begin Date 10/11/2021
Effective End Date
RevisionType:
View all previous versions To request a previous version, contact Customer Service: customerservice@sjm.com, 855-4ST-JUDE (855-478-5833)

Changes to manuals that are designated as "safety" were made to address safety issues.

MRI-Ready Systems Manual
MRI Procedure Information for the Abbott Medical
MR Conditional System

Products, 31 Total

  • CDVRA700Q Avant VR_ICD_UMRI_PR
  • CDVRA800Q NeutrinoNxT VR_ICD_JMRI_PR
  • CDVRA600Q Neutrino NxTVR_ICD_JMRI_PR
  • CDVRA500Q Gallant VR_ICD_BMRI_PR
  • CDVRA300Q Entrant VR_ICD_UMRI_PR
  • CDDRA700Q Avant DR_ICD_BMRI_PR
  • CDDRA800Q NeutrinoNxT DR_ICD_JMRI_PR
  • CDDRA600Q Neutrino NxTDR_ICD_JMRI_PR
  • CDDRA500Q Gallant DR_ICD_UMRI_PR
  • CDDRA300Q Entrant DR_ICD_UMRI_PR
  • CDHFA700Q Avant HF_ICD_BMRI_PR
  • CDHFA800Q NeutrinoNxT HF_ICD_JMRI_PR
  • CDHFA600Q Neutrino NxTHF_ICD_JMRI_PR
  • CDHFA500Q Gallant HF_ICD_UMRI_PR
  • CDHFA300Q Entrant HF_ICD_BMRI_PR
  • 7120Q/58 DURATA LEAD
  • 7120Q/65 DURATA LEAD
  • 7122Q/58 DURATA LEAD
  • 7122Q/65 DURATA LEAD
  • LDA220Q/58 OPTISUREDF4 LEAD DS_U_US
  • LDA220Q/65 OPTISURE LEADDS_U_US
  • LDA210Q/58 OPTISURELEAD SS_U_US
  • LDA210Q/65 OPTISURE LEADSS_U_US
  • 2088TC/46 TENDRIL STS LEAD
  • 2088TC/52 TENDRIL STS LEAD
See All

MRI-Ready Systems Manual
MRI Procedure Information for the Abbott Medical
MR Conditional System

Reorder/Model Numbers, 31 Total

  • 100167336
  • 100167457
  • 100170598
  • 100167386
  • 100167461
  • 100167326
  • 100167443
  • 100170628
  • 100167407
  • 100167390
  • 100167337
  • 100167444
  • 100170670
  • 100167387
  • 100167328
  • 100016969
  • 100016970
  • 100016975
  • 100016976
  • 100075175
  • 100075176
  • 100075173
  • 100075174
  • 100015306
  • 100015307
See All

PDF MRI Procedure Information, Abbott Medical MR Conditional SCS and DRG Systems, Clinician's Manual [PDF 5.36MB] (EN)

Protégé MRI™ IPG, 16 CH, Rechargeable, IPG, 5.3Ah, DRG, Lead Anchor, Butterfly, Lead Anchor, Long, Octrode Lead Kit, 60cm Length, Penta 3mm Lead, 60 cm, Pro More
3771ANS, 3664ANS, 1105ANS, 1106ANS, 3186ANS, 3228ANS, 3772ANS, 3856ANS, 3874ANS, 3875ANS, 1192ANS, 1194ANS, MN10450-50A, 3660ANS, 3662ANS, 3670ABT, 36 More
ARTEN600266404 - A
Effective Begin Date 9/2/2022
Effective End Date
RevisionType:
View all previous versions To request a previous version, contact Customer Service: customerservice@sjm.com, 855-4ST-JUDE (855-478-5833)

Changes to manuals that are designated as "safety" were made to address safety issues.

MRI Procedure Information, Abbott Medical MR Conditional SCS and DRG Systems, Clinician's Manual

Products, 17 Total

  • Protégé MRI™ IPG, 16 CH, Rechargeable
  • IPG, 5.3Ah, DRG
  • Lead Anchor, Butterfly
  • Lead Anchor, Long
  • Octrode Lead Kit, 60cm Length
  • Penta 3mm Lead, 60 cm
  • Prodigy MRI IPG, 16 CH, Rechargeable
  • Prodigy Patient Programmer
  • Clinician Programmer App, 3874
  • Patient Controller App, 3875
  • Swift-Lock Anchor
  • Cinch Lead Anchor
  • 50cm Implant Lead Kit, Slim Tip
  • IPG, 5.3Ah, SCS, SJM
  • IPG, 7.5Ah, SCS, SJM
  • IPG, 5.3Ah, SCS PC New
  • IPG, 7.5Ah, SCS
See All

MRI Procedure Information, Abbott Medical MR Conditional SCS and DRG Systems, Clinician's Manual

Reorder/Model Numbers, 17 Total

  • 3771ANS
  • 3664ANS
  • 1105ANS
  • 1106ANS
  • 3186ANS
  • 3228ANS
  • 3772ANS
  • 3856ANS
  • 3874ANS
  • 3875ANS
  • 1192ANS
  • 1194ANS
  • MN10450-50A
  • 3660ANS
  • 3662ANS
  • 3670ABT
  • 3672ABT
See All

PDF MRI Ready Monitor Systems Manual for Confirm Rx ICM Model DM3500; US [PDF 0.17MB] (EN)

Confirm Rx InsertableCM (DM3500) Welded More
100143791 More
ARTEN600139117 - A
Effective Begin Date 1/18/2021
Effective End Date
RevisionType:
View all previous versions To request a previous version, contact Customer Service: customerservice@sjm.com, 855-4ST-JUDE (855-478-5833)

Changes to manuals that are designated as "safety" were made to address safety issues.

MRI Ready Monitor Systems Manual for Confirm Rx ICM Model DM3500; US

Products, 1 Total

  • Confirm Rx InsertableCM (DM3500) Welded
See All

MRI Ready Monitor Systems Manual for Confirm Rx ICM Model DM3500; US

Reorder/Model Numbers, 1 Total

  • 100143791
See All

PDF MRI Procedure Information, Abbott Medical MR Conditional Deep Brain Stimulation Systems [PDF 4.38MB] (EN)

Guardian Burr Hole Cover, IPG, 5.3 Ah, DBS, SJM, IPG, 7.5 Ah, DBS, SJM, 8CH Infinity DBS Lead Kit, 30cm, 0.5, B, 8CH Infinity DBS Lead Kit, 30cm, 1.5, B, 8 More
6010, 6660ANS, 6662ANS, 6170ANS, 6171ANS, 6172ANS, 6173ANS, 6371ANS, 6372ANS, 6015ANS, 1111ANS More
ARTEN600266405 - A
Effective Begin Date 9/2/2022
Effective End Date
RevisionType:
View all previous versions To request a previous version, contact Customer Service: customerservice@sjm.com, 855-4ST-JUDE (855-478-5833)

Changes to manuals that are designated as "safety" were made to address safety issues.

MRI Procedure Information, Abbott Medical MR Conditional Deep Brain Stimulation Systems

Products, 11 Total

  • Guardian Burr Hole Cover
  • IPG, 5.3 Ah, DBS, SJM
  • IPG, 7.5 Ah, DBS, SJM
  • 8CH Infinity DBS Lead Kit, 30cm, 0.5, B
  • 8CH Infinity DBS Lead Kit, 30cm, 1.5, B
  • 8CH Infinity DBS Lead Kit, 40cm, 0.5, B
  • 8CH Infinity DBS Lead Kit, 40cm, 1.5, B
  • 8CH Infinity DBS Flex Extn Kit, 50cm, B
  • 8CH Infinity DBS Flex Extn Kit, 60cm, B
  • GUARDIAN™ Screw, 5mm, Burr Hole Cover
  • Eon® Port Plug
See All

MRI Procedure Information, Abbott Medical MR Conditional Deep Brain Stimulation Systems

Reorder/Model Numbers, 11 Total

  • 6010
  • 6660ANS
  • 6662ANS
  • 6170ANS
  • 6171ANS
  • 6172ANS
  • 6173ANS
  • 6371ANS
  • 6372ANS
  • 6015ANS
  • 1111ANS
See All

PDF 

AveirTM Link Module Instructions for Use

[PDF 0.89MB] (EN)

LSP112V Aveir VR_Pacer_IDEMRI_US, LSL02, FG, Aveir Link Module,US, IDE, 3650 Merlin PCS, US,with 3330 v6.6.1 SW, 5 LEAD ECG YOKE LABELMODELS 3625, 5 LEAD More
100173657, 600135977, 100002504, 100055011, 100054876 More
ARTEN600186861 - A
Effective Begin Date 3/7/2022
Effective End Date
RevisionType:
View all previous versions To request a previous version, contact Customer Service: customerservice@sjm.com, 855-4ST-JUDE (855-478-5833)

Changes to manuals that are designated as "safety" were made to address safety issues.

AveirTM Link Module Instructions for Use

Products, 5 Total

  • LSP112V Aveir VR_Pacer_IDEMRI_US
  • LSL02, FG, Aveir Link Module,US, IDE
  • 3650 Merlin PCS, US,with 3330 v6.6.1 SW
  • 5 LEAD ECG YOKE LABELMODELS 3625
  • 5 LEAD ECG YOKE LABELMODEL 3626
See All

AveirTM Link Module Instructions for Use

Reorder/Model Numbers, 5 Total

  • 100173657
  • 600135977
  • 100002504
  • 100055011
  • 100054876
See All

PDF 

Pulse Generator and Cardiac Resynchronization Therapy Pulse Generator

User's Manual

[PDF 5.12MB] (EN)

PM1160 Endurity_Pacemaker_U_US, PM1240 Assurity_Pacemaker_U_US, PM1272 Assurity MRI_Pacemaker_U_US, PM2160 Endurity_Pacemaker_U_US, PM2240 Assurity_Pacema More
100069035, 100069046, 100108441, 100069053, 100069070, 100108427, 100080933, 100080935, 100132737, 100132707 More
ARTEN600226857 - A
Effective Begin Date 3/4/2022
Effective End Date
RevisionType:
View all previous versions To request a previous version, contact Customer Service: customerservice@sjm.com, 855-4ST-JUDE (855-478-5833)

Changes to manuals that are designated as "safety" were made to address safety issues.

Pulse Generator and Cardiac Resynchronization Therapy Pulse Generator

User's Manual

Products, 10 Total

  • PM1160 Endurity_Pacemaker_U_US
  • PM1240 Assurity_Pacemaker_U_US
  • PM1272 Assurity MRI_Pacemaker_U_US
  • PM2160 Endurity_Pacemaker_U_US
  • PM2240 Assurity_Pacemaker_U_US
  • PM2272 Assurity MRI_Pacemaker_U_US
  • PM3222 Allure RF_Pacemaker_U_US
  • PM3242 Allure Quadra RF_Pacemaker_U_US
  • PM3542 Quadra Allure_Pacemaker_U_US
  • PM3562 Quadra Allure MP_Pace_JMRI_US
See All

Pulse Generator and Cardiac Resynchronization Therapy Pulse Generator

User's Manual

Reorder/Model Numbers, 10 Total

  • 100069035
  • 100069046
  • 100108441
  • 100069053
  • 100069070
  • 100108427
  • 100080933
  • 100080935
  • 100132737
  • 100132707
See All

PDF Aveir™ Leadless Pacemaker and Delivery Catheter Instructions for Use [PDF 7.49MB] (EN)

3650 Merlin PCS, US,with 3330 v7.1.1 SW, LSP112V Aveir VR_Pacer_IDEMRI_US, LSL02, FG, Aveir Link Module,US, IDE, Aveir VR Del Cath US, IFU Aveir Retrieval More
100014333, 100173657, 600135977, 600174096, 600174816, 600175936 More
ARTEN600175956 - D
Effective Begin Date 4/4/2022
Effective End Date
RevisionType:
View all previous versions To request a previous version, contact Customer Service: customerservice@sjm.com, 855-4ST-JUDE (855-478-5833)

Changes to manuals that are designated as "safety" were made to address safety issues.

Aveir™ Leadless Pacemaker and Delivery Catheter Instructions for Use

Products, 6 Total

  • 3650 Merlin PCS, US,with 3330 v7.1.1 SW
  • LSP112V Aveir VR_Pacer_IDEMRI_US
  • LSL02, FG, Aveir Link Module,US, IDE
  • Aveir VR Del Cath US
  • IFU Aveir Retrieval Catheter US
  • IFU Aveir Introducer DR IDE
See All

Aveir™ Leadless Pacemaker and Delivery Catheter Instructions for Use

Reorder/Model Numbers, 6 Total

  • 100014333
  • 100173657
  • 600135977
  • 600174096
  • 600174816
  • 600175936
See All

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