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PDF 

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

[PDF 1.92MB] (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
ARTEN600261417 - A
Effective Begin Date 8/28/2023
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, 36 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, 36 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-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 Procedure Information, MRC Proclaim™ SCS, Proclaim™ DRG, Prodigy™ SCS, Protégé™ SCS Systems

[PDF 5.36MB] (EN)

Protégé MRI™ IPG, 16 CH, Rechargeable, IPG, 5.3Ah, DRG, Prodigy MRI IPG, 16 CH, Rechargeable, IPG, 5.3Ah, SCS, SJM, IPG, 7.5Ah, SCS, SJM, IPG, 5.3Ah, SCS P More
3771ANS, 3664ANS, 3772ANS, 3660ANS, 3662ANS, 3670ABT, 3672ABT 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, MRC Proclaim™ SCS, Proclaim™ DRG, Prodigy™ SCS, Protégé™ SCS Systems

Products, 7 Total

  • Protégé MRI™ IPG, 16 CH, Rechargeable
  • IPG, 5.3Ah, DRG
  • Prodigy MRI IPG, 16 CH, Rechargeable
  • 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, MRC Proclaim™ SCS, Proclaim™ DRG, Prodigy™ SCS, Protégé™ SCS Systems

Reorder/Model Numbers, 7 Total

  • 3771ANS
  • 3664ANS
  • 3772ANS
  • 3660ANS
  • 3662ANS
  • 3670ABT
  • 3672ABT
See All

PDF MRI-Ready Systems Manual
MRI Procedure Information for the Abbott Medical MR Conditional System [PDF 2.29MB] (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
ARTEN600263177 - A
Effective Begin Date 8/28/2023
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, 49 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, 49 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 Monitor Systems Manual for Jot Dx ICM Model DM4500; US [PDF 0.15MB] (EN)

Next Gen Jot Dx ICM 1.7 More
DM4500 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

  • Next Gen Jot Dx ICM 1.7
See All

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

Reorder/Model Numbers, 1 Total

  • DM4500
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 Ready Monitor Systems Manual [PDF 0.23MB] (EN)

Assert-IQ 3 ICM, ASSERT-IQ 3+ ICM, ASSERT-IQ EL+ ICM More
DM5000, DM5300, DM5500 More
ARTEN600268562 - A
Effective Begin Date 5/4/2023
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

Products, 3 Total

  • Assert-IQ 3 ICM
  • ASSERT-IQ 3+ ICM
  • ASSERT-IQ EL+ ICM
See All

MRI Ready Monitor Systems Manual

Reorder/Model Numbers, 3 Total

  • DM5000
  • DM5300
  • DM5500
See All

PDF MRI Procedure Information, MR Conditional Eterna™ SCS System [PDF 3.59MB] (EN)

Eterna 16-Channel IPG More
32400ABT More
ARTEN600281904 - A
Effective Begin Date 5/19/2023
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, MR Conditional Eterna™ SCS System

Products, 1 Total

  • Eterna 16-Channel IPG
See All

MRI Procedure Information, MR Conditional Eterna™ SCS System

Reorder/Model Numbers, 1 Total

  • 32400ABT
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
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