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Results shown for product or part number 'HeartMate 3 LVAS':


135 Result(s)

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PDF 

HeartMate 3TM  LVAS IFU Addendum – Implant Surgical Techniques Other than Full Median Sternotomy

[PDF 0.16MB] (EN)

LVAS KIT, HM3, HM3 LVAS MINI KIT, PACKAGED ASSEMBLY, OUTFLOW, HM3, APICAL CORING KNIFE, MOD CABLE, STERILE, HM3, ASSEMBLY, TUNNELING LANCE, HM3, HM3 Surgica More
106524US, 10001696, 105581US, 1050, 106525US, 10010372GBL, 10002222US, 28717, 106522US, 106528US, 106532US, 106534US, 106526US, 10012390GBL, 106531US, More
100167359 - A
Effective Begin Date 8/26/2020
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.

HeartMate 3TM  LVAS IFU Addendum – Implant Surgical Techniques Other than Full Median Sternotomy

Products, 40 Total

  • LVAS KIT, HM3
  • HM3 LVAS MINI KIT
  • PACKAGED ASSEMBLY, OUTFLOW, HM3
  • APICAL CORING KNIFE
  • MOD CABLE, STERILE, HM3
  • ASSEMBLY, TUNNELING LANCE, HM3
  • HM3 Surgical Hand Tools
  • Explant Return Kit
  • ASSY, SHELF BOX HM3 APICAL CUFF
  • ASSY, SHELF BOX HM3 SKIN CORING PUNCH
  • ASSY, SHELF BOX HM3 THREAD PROTECTORS
  • ASSY, SHELF BOX HM3 TUNNELING ADAPTER
  • MOD CABLE CAP, (PKG OF 3) HM3
  • Outflow Fixation clip, HeartMate 3
  • SYSTEM CONTROLLER WITH EBB, HM3
  • HeartMate-CTRL BTT-11V LI-ION
  • POWER MODULE, NORTH AMERICA
  • HeartMate-MOBILE POWER UNIT,NA
  • AC POWER CORD, MPU, HMII, NA
  • UNIVERSAL BATTERY CHARGER, NORTH AM
  • 14 V LI-ION BATTERY
  • HM II 14V LI-ION BATTERY CLIP SET
  • SINGLE BATTERY - PM
  • HM POWER MODULE 14V PATIENT CABLE
  • AC POWER CORD, NO. AMERICA,PACKAGED
See All

HeartMate 3TM  LVAS IFU Addendum – Implant Surgical Techniques Other than Full Median Sternotomy

Reorder/Model Numbers, 40 Total

  • 106524US
  • 10001696
  • 105581US
  • 1050
  • 106525US
  • 10010372GBL
  • 10002222US
  • 28717
  • 106522US
  • 106528US
  • 106532US
  • 106534US
  • 106526US
  • 10012390GBL
  • 106531US
  • 106128
  • 1340
  • 107754
  • 107760
  • 1440
  • 2465
  • 2865
  • 109200
  • 103426
  • 103860
See All

PDF HeartMate II™ LVAS
Instructions for Use
Featuring the Mobile Power Unit [PDF 7.63MB] (EN)

LVAS KIT,POCKET CTRL,HMII,US,SEALED, PACKAGED & STERILIZED SEALED INFLOW, HeartMate II-SEALED OG-STER, HeartMate II-SEALED OUTFLOW BR, PKG & LABELING SOBR More
106015, 104142, 103393, 104692, 107315, 105557, 105558, 102137, 102772, 102138, 107794, 1050, 1065, 28717, B106101, B106102, 107859, 106762, 106128, 1 More
100175721 - A
Effective Begin Date 3/17/2021
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.

HeartMate II™ LVAS
Instructions for Use
Featuring the Mobile Power Unit

Products, 44 Total

  • LVAS KIT,POCKET CTRL,HMII,US,SEALED
  • PACKAGED & STERILIZED SEALED INFLOW
  • HeartMate II-SEALED OG-STER
  • HeartMate II-SEALED OUTFLOW BR
  • PKG & LABELING SOBR,COLLAR,STERILE
  • PKG LBL SKN CORING STERILE HMII
  • PKG LBL THREAD PROTECT HMII
  • TRAV, TUNNELER HM II
  • HeartMate II-SURGICAL SIZER
  • TRAV, SPANNER WRENCH, HM II
  • HeartMate II-DEMO PUMP KIT-PKT
  • APICAL CORING KNIFE
  • APICAL SEWING RING/STERL,(SET OF 3)
  • Explant Return Kit
  • HeartMate II-PT SUP KT-PKT-EQ
  • HeartMate II-PT SUP KT-PKT
  • HeartMate II-POCKET CTRL DEMO
  • POCKET CONTRLR PKG,HMII STERILE NA
  • HeartMate-CTRL BTT-11V LI-ION
  • POWER MODULE, NORTH AMERICA
  • HeartMate-MOBILE POWER UNIT,NA
  • UNIVERSAL BATTERY CHARGER, NORTH AM
  • 14 V LI-ION BATTERY
  • HM II 14V LI-ION BATTERY CLIP SET
  • SINGLE BATTERY, ENERGIZER
See All

HeartMate II™ LVAS
Instructions for Use
Featuring the Mobile Power Unit

Reorder/Model Numbers, 44 Total

  • 106015
  • 104142
  • 103393
  • 104692
  • 107315
  • 105557
  • 105558
  • 102137
  • 102772
  • 102138
  • 107794
  • 1050
  • 1065
  • 28717
  • B106101
  • B106102
  • 107859
  • 106762
  • 106128
  • 1340
  • 107754
  • 1440
  • 2465
  • 2865
  • 102808
See All

PDF HeartMate TouchTM Communication System Quick Start Guide (NA) [PDF 1.06MB] (EN)

HeartMate Touch Kit, HeartMate Touch Kit Rental, LVAS KIT, HM3, HM3 LVAS MINI KIT, PACKAGED ASSEMBLY, OUTFLOW (US), APICAL CORING KNIFE, MOD CABLE, STERILE, More
HMT1100, HMT1100-R, 106524US, 10001696, 105581US, 1050, 106525US, 10010372GBL, 10002222US, 28717, 106526US, 10012390GBL, 106528US, 106522US, 106534US, More
100167125 - B
Effective Begin Date 8/11/2020
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.

HeartMate TouchTM Communication System Quick Start Guide (NA)

Products, 41 Total

  • HeartMate Touch Kit
  • HeartMate Touch Kit Rental
  • LVAS KIT, HM3
  • HM3 LVAS MINI KIT
  • PACKAGED ASSEMBLY, OUTFLOW (US)
  • APICAL CORING KNIFE
  • MOD CABLE, STERILE, HM3
  • ASSEMBLY, TUNNELING LANCE, HM3
  • HM3 Surgical Hand Tools
  • Explant Return Kit
  • MOD CABLE CAP, (PKG OF 3) HM3
  • Outflow Fixation clip, HeartMate 3
  • ASSY, SHELF BOX HM3 SKIN CORING PUNCH
  • ASSY, SHELF BOX HM3 APICAL CUFF
  • ASSY, SHELF BOX HM3 TUNNELING ADAPTER
  • SYSTEM CONTROLLER WITH EBB, HM3
  • HeartMate-CTRL BTT-11V LI-ION
  • POWER MODULE, NORTH AMERICA
  • HeartMate-MOBILE POWER UNIT,NA
  • AC POWER CORD, MPU, HMII, NA
  • UNIVERSAL BATTERY CHARGER, NORTH AM
  • 14 V LI-ION BATTERY
  • HM II 14V LI-ION BATTERY CLIP SET
  • SINGLE BATTERY - PM
  • HM POWER MODULE 14V PATIENT CABLE
See All

HeartMate TouchTM Communication System Quick Start Guide (NA)

Reorder/Model Numbers, 41 Total

  • HMT1100
  • HMT1100-R
  • 106524US
  • 10001696
  • 105581US
  • 1050
  • 106525US
  • 10010372GBL
  • 10002222US
  • 28717
  • 106526US
  • 10012390GBL
  • 106528US
  • 106522US
  • 106534US
  • 106531US
  • 106128
  • 1340
  • 107754
  • 107760
  • 1440
  • 2465
  • 2865
  • 109200
  • 103426
See All

PDF Inflow Conduit and Outflow Graft Addendum to Heartmate™ II Instructions for Use [PDF 0.05MB] (EN)

HeartMate Touch Kit, HeartMate Touch Kit Rental, LVAS KIT,POCKET CTRL,HMII,US,SEALED, PACKAGED & STERILIZED SEALED INFLOW, HeartMate II-SEALED OG-STER, Hea More
HMT1100, HMT1100-R, 106015, 104142, 103393, 104692, 107315, 105557, 105558, 102137, 102772, 102138, 107794, 1050, 1065, 28717, B106101, B106102, 10785 More
100175809 - A
Effective Begin Date 12/17/2020
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.

Inflow Conduit and Outflow Graft Addendum to Heartmate™ II Instructions for Use

Products, 50 Total

  • HeartMate Touch Kit
  • HeartMate Touch Kit Rental
  • LVAS KIT,POCKET CTRL,HMII,US,SEALED
  • PACKAGED & STERILIZED SEALED INFLOW
  • HeartMate II-SEALED OG-STER
  • HeartMate II-SEALED OUTFLOW BR
  • PKG & LABELING SOBR,COLLAR,STERILE
  • PKG LBL SKN CORING STERILE HMII
  • PKG LBL THREAD PROTECT HMII
  • TRAV, TUNNELER HM II
  • HeartMate II-SURGICAL SIZER
  • TRAV, SPANNER WRENCH, HM II
  • HeartMate II-DEMO PUMP KIT-PKT
  • APICAL CORING KNIFE
  • APICAL SEWING RING/STERL,(SET OF 3)
  • Explant Return Kit
  • HeartMate II-PT SUP KT-PKT-EQ
  • HeartMate II-PT SUP KT-PKT
  • HeartMate II-POCKET CTRL DEMO
  • POCKET CONTRLR PKG,HMII STERILE NA
  • HeartMate-CTRL BTT-11V LI-ION
  • POWER MODULE, NORTH AMERICA
  • HeartMate-MOBILE POWER UNIT,NA
  • UNIVERSAL BATTERY CHARGER, NORTH AM
  • 14 V LI-ION BATTERY
See All

Inflow Conduit and Outflow Graft Addendum to Heartmate™ II Instructions for Use

Reorder/Model Numbers, 50 Total

  • HMT1100
  • HMT1100-R
  • 106015
  • 104142
  • 103393
  • 104692
  • 107315
  • 105557
  • 105558
  • 102137
  • 102772
  • 102138
  • 107794
  • 1050
  • 1065
  • 28717
  • B106101
  • B106102
  • 107859
  • 106762
  • 106128
  • 1340
  • 107754
  • 1440
  • 2465
See All

PDF HeartMate Touch HMII LVAS IFU (NA) [PDF 8.55MB] (EN)

HeartMate Touch Kit, HeartMate Touch Kit Rental, LVAS KIT,POCKET CTRL,HMII,US,SEALED, PACKAGED & STERILIZED SEALED INFLOW, HeartMate II-SEALED OG-STER, Hea More
HMT1100, HMT1100-R, 106015, 104142, 103393, 104692, 107315, 105557, 105558, 102137, 102772, 102138, 107794, 1050, 1065, 28717, B106101, B106102, 10785 More
100168923 - B
Effective Begin Date 8/11/2020
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.

HeartMate Touch HMII LVAS IFU (NA)

Products, 45 Total

  • HeartMate Touch Kit
  • HeartMate Touch Kit Rental
  • LVAS KIT,POCKET CTRL,HMII,US,SEALED
  • PACKAGED & STERILIZED SEALED INFLOW
  • HeartMate II-SEALED OG-STER
  • HeartMate II-SEALED OUTFLOW BR
  • PKG & LABELING SOBR,COLLAR,STERILE
  • PKG LBL SKN CORING STERILE HMII
  • PKG LBL THREAD PROTECT HMII
  • TRAV, TUNNELER HM II
  • HeartMate II-SURGICAL SIZER
  • TRAV, SPANNER WRENCH, HM II
  • HeartMate II-DEMO PUMP KIT-PKT
  • APICAL CORING KNIFE
  • APICAL SEWING RING/STERL,(SET OF 3)
  • Explant Return Kit
  • HeartMate II-PT SUP KT-PKT-EQ
  • HeartMate II-PT SUP KT-PKT
  • HeartMate II-POCKET CTRL DEMO
  • POCKET CONTRLR PKG,HMII STERILE NA
  • HeartMate-CTRL BTT-11V LI-ION
  • POWER MODULE, NORTH AMERICA
  • HeartMate-MOBILE POWER UNIT,NA
  • UNIVERSAL BATTERY CHARGER, NORTH AM
  • 14 V LI-ION BATTERY
See All

HeartMate Touch HMII LVAS IFU (NA)

Reorder/Model Numbers, 45 Total

  • HMT1100
  • HMT1100-R
  • 106015
  • 104142
  • 103393
  • 104692
  • 107315
  • 105557
  • 105558
  • 102137
  • 102772
  • 102138
  • 107794
  • 1050
  • 1065
  • 28717
  • B106101
  • B106102
  • 107859
  • 106762
  • 106128
  • 1340
  • 107754
  • 1440
  • 2465
See All

PDF HeartMate 3TM  Left Ventricular Assist System Instructions For Use with System Monitor II [PDF 44.19MB] (EN)

LVAS KIT, HM3, HM3 LVAS MINI KIT, PACKAGED ASSEMBLY, OUTFLOW (US), MOD CABLE, STERILE, HM3, HM3 TUNNELER, HM3 Surgical Hand Tools, Explant Return Kit, MOD CA More
106524US, 10001696, 105581US, 106525US, 106533US, 10002222US, 28717, 106526US, 10012390GBL, 106531US, 106128, 107754, 107760, 109200, 103426, 103860, More
100176253 - A
Effective Begin Date 12/23/2020
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.

HeartMate 3TM  Left Ventricular Assist System Instructions For Use with System Monitor II

Products, 41 Total

  • LVAS KIT, HM3
  • HM3 LVAS MINI KIT
  • PACKAGED ASSEMBLY, OUTFLOW (US)
  • MOD CABLE, STERILE, HM3
  • HM3 TUNNELER
  • HM3 Surgical Hand Tools
  • Explant Return Kit
  • MOD CABLE CAP, (PKG OF 3) HM3
  • Outflow Fixation clip, HeartMate 3
  • SYSTEM CONTROLLER WITH EBB, HM3
  • HeartMate-CTRL BTT-11V LI-ION
  • HeartMate-MOBILE POWER UNIT,NA
  • AC POWER CORD, MPU, HMII, NA
  • SINGLE BATTERY - PM
  • HM POWER MODULE 14V PATIENT CABLE
  • AC POWER CORD, NO. AMERICA,PACKAGED
  • CF CARD, INSPECTED AND LABELED
  • HeartMate-CARD READER SANDISK
  • HEARTMATE SM TO PM CABLE
  • G2 WCA WEARABLE ACCESSORIES KIT
  • G2 WCA CONSOLIDATED BAG, LEFT
  • G2 WCA CONSOLIDATED BAG, RIGHT
  • G2 WCA HOLSTER VEST, SMALL
  • G2 WCA HOLSTER VEST, MEDIUM
  • G2 WCA HOLSTER VEST, LARGE
See All

HeartMate 3TM  Left Ventricular Assist System Instructions For Use with System Monitor II

Reorder/Model Numbers, 41 Total

  • 106524US
  • 10001696
  • 105581US
  • 106525US
  • 106533US
  • 10002222US
  • 28717
  • 106526US
  • 10012390GBL
  • 106531US
  • 106128
  • 107754
  • 107760
  • 109200
  • 103426
  • 103860
  • 101609
  • 102504
  • 103859
  • 106129
  • 106449
  • 104233
  • 104229
  • 104230
  • 104231
See All

PDF 

Recommendations for Disinfectant Agents      Addendum to the HM IITM and HM 3TM Instructions for Use

[PDF 0.07MB] (EN)

SYSTEM CONTROLLER WITH EBB, HM3, System Controller, HM 3, Low Flow 2.0, LVAS KIT, HM3, MOD CABLE, STERILE, HM3, HeartMate II-LVAD Kit-PKT, NA, HeartMate-BA More
106531US, 106531LF2, 106524US, 106525US, B106015, MOD_L1440-TS, 2465, 2865, 106128, L1340, 103426, 103860, 107760, 107754, 104233, 106449, 104229, 104 More
ARTEN600227460 - A
Effective Begin Date 4/22/2022
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.

Recommendations for Disinfectant Agents      Addendum to the HM IITM and HM 3TM Instructions for Use

Products, 36 Total

  • SYSTEM CONTROLLER WITH EBB, HM3
  • System Controller, HM 3, Low Flow 2.0
  • LVAS KIT, HM3
  • MOD CABLE, STERILE, HM3
  • HeartMate II-LVAD Kit-PKT, NA
  • HeartMate-BATTERY CHARGER,CSI
  • 14 V LI-ION BATTERY
  • HM II 14V LI-ION BATTERY CLIP SET
  • HeartMate-CTRL BTT-11V LI-ION
  • HeartMate-POWER MODULE-REN
  • HM POWER MODULE 14V PATIENT CABLE
  • AC POWER CORD, NO. AMERICA,PACKAGED
  • AC POWER CORD, MPU, HMII, NA
  • HeartMate-MOBILE POWER UNIT,NA
  • G2 WCA CONSOLIDATED BAG, RIGHT
  • G2 WCA CONSOLIDATED BAG, LEFT
  • G2 WCA HOLSTER VEST, SMALL
  • G2 WCA HOLSTER VEST, MEDIUM
  • G2 WCA HOLSTER VEST, LARGE
  • G2 WCA WEARABLE ACCESSORIES KIT
  • G2 WCA BATTERY HOLSTER
  • TRAV, G2 WCA SHOWER BAG
  • HeartMate II-TRAVEL BAG
  • ASSY, HM ICU COVER, 6-PACK (HM II & HM3)
  • ASSY, HM ICU COVER, 1-PACK (HM II & HM3)
See All

Recommendations for Disinfectant Agents      Addendum to the HM IITM and HM 3TM Instructions for Use

Reorder/Model Numbers, 36 Total

  • 106531US
  • 106531LF2
  • 106524US
  • 106525US
  • B106015
  • MOD_L1440-TS
  • 2465
  • 2865
  • 106128
  • L1340
  • 103426
  • 103860
  • 107760
  • 107754
  • 104233
  • 106449
  • 104229
  • 104230
  • 104231
  • 106129
  • 104234
  • 104232
  • 1260
  • 10002151
  • 10003491
See All

PDF 

HeartMate 3TM Left Ventricular Assist System Instructions For Use with HeartMate Touch

[PDF 18.15MB] (EN)

HeartMate Touch Kit Rental, HeartMate Touch Kit, LVAS KIT, HM3, HM3 LVAS MINI KIT, PACKAGED ASSEMBLY, OUTFLOW (US), APICAL CORING KNIFE, MOD CABLE, STERILE, More
HMT1100-R, HMT1100, 106524US, 10001696, 105581US, 1050, 106525US, 10010372GBL, 10002222US, 28717, 106526US, 10012390GBL, 106528US, 106522US, 106534US, More
ARTEN600200959 - A
Effective Begin Date 6/8/2022
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.

HeartMate 3TM Left Ventricular Assist System Instructions For Use with HeartMate Touch

Products, 42 Total

  • HeartMate Touch Kit Rental
  • HeartMate Touch Kit
  • LVAS KIT, HM3
  • HM3 LVAS MINI KIT
  • PACKAGED ASSEMBLY, OUTFLOW (US)
  • APICAL CORING KNIFE
  • MOD CABLE, STERILE, HM3
  • ASSEMBLY, TUNNELING LANCE, HM3
  • HM3 Surgical Hand Tools
  • Explant Return Kit
  • MOD CABLE CAP, (PKG OF 3) HM3
  • Outflow Fixation clip, HeartMate 3
  • ASSY, SHELF BOX HM3 SKIN CORING PUNCH
  • ASSY, SHELF BOX HM3 APICAL CUFF
  • ASSY, SHELF BOX HM3 TUNNELING ADAPTER
  • ASSY, SHELF BOX HM3 THREAD PROTECTORS
  • SYSTEM CONTROLLER WITH EBB, HM3
  • HeartMate-CTRL BTT-11V LI-ION
  • POWER MODULE, NORTH AMERICA
  • HeartMate-MOBILE POWER UNIT,NA
  • AC POWER CORD, MPU, HMII, NA
  • UNIVERSAL BATTERY CHARGER, NORTH AM
  • 14 V LI-ION BATTERY
  • HM II 14V LI-ION BATTERY CLIP (PKG OF 2)
  • SINGLE BATTERY - PM
See All

HeartMate 3TM Left Ventricular Assist System Instructions For Use with HeartMate Touch

Reorder/Model Numbers, 42 Total

  • HMT1100-R
  • HMT1100
  • 106524US
  • 10001696
  • 105581US
  • 1050
  • 106525US
  • 10010372GBL
  • 10002222US
  • 28717
  • 106526US
  • 10012390GBL
  • 106528US
  • 106522US
  • 106534US
  • 106532US
  • 106531US
  • 106128
  • 1340
  • 107754
  • 107760
  • 1440
  • 2465
  • 2865
  • 109200
See All

PDF Intensive Care Unit (ICU) Cover Addendum to the HeartMate™ II Instructions for Use [PDF 0.7MB] (EN,FR,ES)

ASSY, HM ICU COVER, 6-PACK (HM II & HM3), ASSY, HM ICU COVER, 1-PACK (HM II & HM3), LVAS KIT,POCKET CTRL,HMII,US,SEALED, HMII PUMP & POCKET SYSTEM CTRL O More
10002151, 10003491, 106015, 107801 More
10008480 - B
Effective Begin Date 1/29/2021
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.

Intensive Care Unit (ICU) Cover Addendum to the HeartMate™ II Instructions for Use

Products, 4 Total

  • ASSY, HM ICU COVER, 6-PACK (HM II & HM3)
  • ASSY, HM ICU COVER, 1-PACK (HM II & HM3)
  • LVAS KIT,POCKET CTRL,HMII,US,SEALED
  • HMII PUMP & POCKET SYSTEM CTRL ONLY
See All

Intensive Care Unit (ICU) Cover Addendum to the HeartMate™ II Instructions for Use

Reorder/Model Numbers, 4 Total

  • 10002151
  • 10003491
  • 106015
  • 107801
See All

PDF HeartMate 3™
Left Ventricular Assist System
Configuring the Backup System Controller [PDF 0.92MB] (EN)

SYSTEM CONTROLLER WITH EBB, HM3, MOD CABLE, STERILE, HM3, MOD CABLE, STERILE, HM3, HeartMate-CTRL BTT-11V LI-ION, HeartMate-CTRL BTT-11V LI-ION, POWER MODU More
106531US, 106525US, MOD_106525US, 106128, MOD_000000000000106128, 1340, 2465, 109200, MOD_000000000000109200, 103426, MOD_000000000000103426, 103860, More
ARTEN600231144 - A
Effective Begin Date 6/10/2022
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.

HeartMate 3™
Left Ventricular Assist System
Configuring the Backup System Controller

Products, 18 Total

  • SYSTEM CONTROLLER WITH EBB, HM3
  • MOD CABLE, STERILE, HM3
  • MOD CABLE, STERILE, HM3
  • HeartMate-CTRL BTT-11V LI-ION
  • HeartMate-CTRL BTT-11V LI-ION
  • POWER MODULE, NORTH AMERICA
  • 14 V LI-ION BATTERY
  • SINGLE BATTERY - PM
  • SINGLE BATTERY - PM
  • HM POWER MODULE 14V PATIENT CABLE
  • HM POWER MODULE 14V PATIENT CABLE
  • AC POWER CORD, NO. AMERICA,PACKAGED
  • AC POWER CORD, BRAZIL, PACKAGED
  • HeartMate II-SYSTEM MONITOR
  • CF CARD, INSPECTED AND LABELED
  • CF CARD, INSPECTED AND LABELED
  • HEARTMATE SM TO PM CABLE
  • HEARTMATE SM TO PM CABLE
See All

HeartMate 3™
Left Ventricular Assist System
Configuring the Backup System Controller

Reorder/Model Numbers, 18 Total

  • 106531US
  • 106525US
  • MOD_106525US
  • 106128
  • MOD_000000000000106128
  • 1340
  • 2465
  • 109200
  • MOD_000000000000109200
  • 103426
  • MOD_000000000000103426
  • 103860
  • 103860BR
  • 1286
  • 101609
  • MOD_000000000000101609
  • 103859
  • MOD_000000000000103859
See All

PDF HeartMate 3™ LVAS
Alarms for Clinicians [PDF 0.24MB] (EN)

SYSTEM CONTROLLER WITH EBB, HM3, HeartMate-CTRL BTT-11V LI-ION, POWER MODULE, NORTH AMERICA, HeartMate-MOBILE POWER UNIT,NA, AC POWER CORD, MPU, HMII, NA, More
106531US, 106128, 1340, 107754, 107760, 1440, 2465, 2865, 109200, 103426, 103860 More
ARTEN600230799 - A
Effective Begin Date 6/10/2022
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.

HeartMate 3™ LVAS
Alarms for Clinicians

Products, 11 Total

  • SYSTEM CONTROLLER WITH EBB, HM3
  • HeartMate-CTRL BTT-11V LI-ION
  • POWER MODULE, NORTH AMERICA
  • HeartMate-MOBILE POWER UNIT,NA
  • AC POWER CORD, MPU, HMII, NA
  • UNIVERSAL BATTERY CHARGER, NORTH AM
  • 14 V LI-ION BATTERY
  • HM II 14V LI-ION BATTERY CLIP (PKG OF 2)
  • SINGLE BATTERY - PM
  • HM POWER MODULE 14V PATIENT CABLE
  • AC POWER CORD, NO. AMERICA,PACKAGED
See All

HeartMate 3™ LVAS
Alarms for Clinicians

Reorder/Model Numbers, 11 Total

  • 106531US
  • 106128
  • 1340
  • 107754
  • 107760
  • 1440
  • 2465
  • 2865
  • 109200
  • 103426
  • 103860
See All

PDF HeartMate 3™ LVAS
Alarms for Clinicians [PDF 0.71MB] (EN)

SYSTEM CONTROLLER WITH EBB, HM3, HeartMate-CTRL BTT-11V LI-ION, POWER MODULE, NORTH AMERICA, HeartMate-MOBILE POWER UNIT,NA, AC POWER CORD, MPU, HMII, NA, More
106531US, 106128, 1340, 107754, 107760, 1440, 2465, 2865, 109200, 103426, 103860 More
ARTEN600214217 - A
Effective Begin Date 6/10/2022
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.

HeartMate 3™ LVAS
Alarms for Clinicians

Products, 11 Total

  • SYSTEM CONTROLLER WITH EBB, HM3
  • HeartMate-CTRL BTT-11V LI-ION
  • POWER MODULE, NORTH AMERICA
  • HeartMate-MOBILE POWER UNIT,NA
  • AC POWER CORD, MPU, HMII, NA
  • UNIVERSAL BATTERY CHARGER, NORTH AM
  • 14 V LI-ION BATTERY
  • HM II 14V LI-ION BATTERY CLIP (PKG OF 2)
  • SINGLE BATTERY - PM
  • HM POWER MODULE 14V PATIENT CABLE
  • AC POWER CORD, NO. AMERICA,PACKAGED
See All

HeartMate 3™ LVAS
Alarms for Clinicians

Reorder/Model Numbers, 11 Total

  • 106531US
  • 106128
  • 1340
  • 107754
  • 107760
  • 1440
  • 2465
  • 2865
  • 109200
  • 103426
  • 103860
See All

PDF Trifecta™ Sizer Set Instructions for Use [PDF 1.76MB] (EN,BG,CS,DA,NL,EL,ES,ET,FI,FR,DE,HU,IT,KO,LT,NO,PL,PT,RO,SK,SV,TR)

ACCESSORY KIT, TRIFECTA, SIZER, TRIFECTA, 19MM, SIZER, TRIFECTA, 21MM, SIZER, TRIFECTA, 23MM, SIZER, TRIFECTA, 25MM, SIZER, TRIFECTA, 27MM, SIZER, TRIFECTA, More
TF2000, TF2000-19, TF2000-21, TF2000-23, TF2000-25, TF2000-27, TF2000-29 More
ARTMT100103562 - B
Effective Begin Date 2/7/2018
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.

Trifecta™ Sizer Set Instructions for Use

Products, 7 Total

  • ACCESSORY KIT, TRIFECTA
  • SIZER, TRIFECTA, 19MM
  • SIZER, TRIFECTA, 21MM
  • SIZER, TRIFECTA, 23MM
  • SIZER, TRIFECTA, 25MM
  • SIZER, TRIFECTA, 27MM
  • SIZER, TRIFECTA, 29MM
See All

Trifecta™ Sizer Set Instructions for Use

Reorder/Model Numbers, 7 Total

  • TF2000
  • TF2000-19
  • TF2000-21
  • TF2000-23
  • TF2000-25
  • TF2000-27
  • TF2000-29
See All

PDF Sustain XL User's Manual [PDF 2.25MB] (EN)

PM1134 Sustain XL SCPacemaker_C_US, PM1136 Sustain XL SRPacemaker_U_US, PM2134 Sustain XL DCPacemaker_B_US, PM2136 Sustain XL DRPacemaker_B_US More
100045989, 100045930, 100045955, 100045953 More
40008243 - B
Effective Begin Date 7/6/2016
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.

Sustain XL User's Manual

Products, 4 Total

  • PM1134 Sustain XL SCPacemaker_C_US
  • PM1136 Sustain XL SRPacemaker_U_US
  • PM2134 Sustain XL DCPacemaker_B_US
  • PM2136 Sustain XL DRPacemaker_B_US
See All

Sustain XL User's Manual

Reorder/Model Numbers, 4 Total

  • 100045989
  • 100045930
  • 100045955
  • 100045953
See All

PDF Trifecta™ Valve with Glide™ Technology (GT) Instructions for Use [PDF 0.81MB] (EN)

19mm Trifecta GT Final Package - WR, 21mm Trifecta GT Final Package - WR, 23mm Trifecta GT Final Package - WR, 25mm Trifecta GT Final Package - WR, 27mm T More
TFGT-19A, TFGT-21A, TFGT-23A, TFGT-25A, TFGT-27A, TFGT-29A More
ARTEN600065187 - A
Effective Begin Date 8/30/2019
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.

Trifecta™ Valve with Glide™ Technology (GT) Instructions for Use

Products, 6 Total

  • 19mm Trifecta GT Final Package - WR
  • 21mm Trifecta GT Final Package - WR
  • 23mm Trifecta GT Final Package - WR
  • 25mm Trifecta GT Final Package - WR
  • 27mm Trifecta GT Final Package - WR
  • 29mm Trifecta GT Final Package - WR
See All

Trifecta™ Valve with Glide™ Technology (GT) Instructions for Use

Reorder/Model Numbers, 6 Total

  • TFGT-19A
  • TFGT-21A
  • TFGT-23A
  • TFGT-25A
  • TFGT-27A
  • TFGT-29A
See All

PDF 

Quartet™ 1457Q Left Ventricular Heart Lead IDE Clinical Summary

[PDF 0.27MB] (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
ARTEN600131716 - 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.

Quartet™ 1457Q Left Ventricular Heart Lead IDE 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

Quartet™ 1457Q Left Ventricular Heart Lead IDE 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 EpicTM Plus/EpicTM Plus Supra
Stented Porcine Tissue Valves
Intructions for Use [PDF 0.57MB] (EN)

Epic Plus Mitral, 33mm, Epic Plus Mitral, 31mm, Epic Plus Mitral, 29mm, Epic Plus Aortic, 29mm, Epic Plus Mitral, 27mm, Epic Plus Aortic, 27mm, Epic Plus Mi More
E200-33M, E200-31M, E200-29M, E200-29A, E200-27M, E200-27A, E200-25M, E200-25A, E200-23A, E200-21A, ESP200-19, ESP200-21, ESP200-23, ESP200-25, ESP200 More
ARTEN600181537 - D
Effective Begin Date 12/17/2021
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.

EpicTM Plus/EpicTM Plus Supra
Stented Porcine Tissue Valves
Intructions for Use

Products, 15 Total

  • Epic Plus Mitral, 33mm
  • Epic Plus Mitral, 31mm
  • Epic Plus Mitral, 29mm
  • Epic Plus Aortic, 29mm
  • Epic Plus Mitral, 27mm
  • Epic Plus Aortic, 27mm
  • Epic Plus Mitral, 25mm
  • Epic Plus Aortic, 25mm
  • Epic Plus Aortic, 23mm
  • Epic Plus Aortic, 21mm
  • Epic Plus Supra, 19mm
  • Epic Plus Supra, 21mm
  • Epic Plus Supra, 23mm
  • Epic Plus Supra, 25mm
  • Epic Plus Supra, 27mm
See All

EpicTM Plus/EpicTM Plus Supra
Stented Porcine Tissue Valves
Intructions for Use

Reorder/Model Numbers, 15 Total

  • E200-33M
  • E200-31M
  • E200-29M
  • E200-29A
  • E200-27M
  • E200-27A
  • E200-25M
  • E200-25A
  • E200-23A
  • E200-21A
  • ESP200-19
  • ESP200-21
  • ESP200-23
  • ESP200-25
  • ESP200-27
See All

PDF US Ablation Therapy Device Compatibility Matrix [PDF 0.05MB] (EN)

1304-CP2S-8-25-MS-BD-ME, 1304-CP2S-8-25-MC-BD-ME, 1304-CP2S-8-25-LS-BD-ME, 1304-CP2S-8-25-LC-BD-ME, 1304-CP2-8-25-MS-BD-ME, 1304-CP2-8-25-MC-BD-ME, 1304-CP2 More
100072246, 100072247, 100072248, 100072249, 100072250, 100072261, 100072262, 100072263, 100080455, 100080456, 100080457, 100080458, 85641, IBI-85641, More
ARTEN100121329 - C
Effective Begin Date 2/24/2017
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.

US Ablation Therapy Device Compatibility Matrix

Products, 136 Total

  • 1304-CP2S-8-25-MS-BD-ME
  • 1304-CP2S-8-25-MC-BD-ME
  • 1304-CP2S-8-25-LS-BD-ME
  • 1304-CP2S-8-25-LC-BD-ME
  • 1304-CP2-8-25-MS-BD-ME
  • 1304-CP2-8-25-MC-BD-ME
  • 1304-CP2-8-25-LS-BD-ME
  • 1304-CP2-8-25-LC-BD-ME
  • 1304-CP2-7-25-MS-BD
  • 1304-CP2-7-25-MC-BD
  • 1304-CP2-7-25-LS-BD
  • 1304-CP2-7-25-LC-BD
  • 1641 CABLE
  • 1641 CABLE
  • 1711-M CABLE
  • 1713-W CABLE
  • 1739-W CABLE
  • 1763-E CABLE
  • 1778-E CABLE
  • EPTC EXT CABLE 150CM
  • SAFIRE CABLE EPT1000 TC150(US)
  • SAFIRE CABLE EPT1000 TC300(US)
  • SAFIRE CBL STKRT70 150CM (US)
  • SAFIRE CBL STKRT70 300CM (US)
  • SAFIRE EXT CBL 150CM IBI 100W
See All

US Ablation Therapy Device Compatibility Matrix

Reorder/Model Numbers, 136 Total

  • 100072246
  • 100072247
  • 100072248
  • 100072249
  • 100072250
  • 100072261
  • 100072262
  • 100072263
  • 100080455
  • 100080456
  • 100080457
  • 100080458
  • 85641
  • IBI-85641
  • 85711
  • 85713
  • 85739
  • 85763
  • 85778
  • 402518
  • 402549
  • 402550
  • 402553
  • 402554
  • 402569
See All

PDF 

Trial and Implant Lead Kits for DRG Neurostimulation Systems, Lead Extension and Tunneling Tool Kits

[PDF 2.01MB] (EN)

50cm Trial Lead Kit, Slim Tip, 90cm Trial Lead Kit, Slim Tip, 50cm Implant Lead Kit, Slim Tip, 90cm Implant Lead Kit, Slim Tip, Lead Extension Kit, 30cm Tu More
MN10350-50A, MN10350-90A, MN10450-50A, MN10450-90A, MN10550-50, MN15000, MN12050, MN12150, MN13650, MN11350, MN14000 More
ARTEN600021278 - A
Effective Begin Date 7/31/2018
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.

Trial and Implant Lead Kits for DRG Neurostimulation Systems, Lead Extension and Tunneling Tool Kits

Products, 11 Total

  • 50cm Trial Lead Kit, Slim Tip
  • 90cm Trial Lead Kit, Slim Tip
  • 50cm Implant Lead Kit, Slim Tip
  • 90cm Implant Lead Kit, Slim Tip
  • Lead Extension Kit
  • 30cm Tunneling Tool
  • Lead Accessories Kit
  • 22cm Small Curve Delivery Sheath Kit
  • 22cm Big Curve Delivery Sheath Kit
  • Connector Cable Kit
  • Curved Needle
See All

Trial and Implant Lead Kits for DRG Neurostimulation Systems, Lead Extension and Tunneling Tool Kits

Reorder/Model Numbers, 11 Total

  • MN10350-50A
  • MN10350-90A
  • MN10450-50A
  • MN10450-90A
  • MN10550-50
  • MN15000
  • MN12050
  • MN12150
  • MN13650
  • MN11350
  • MN14000
See All

PDF Performance of Chamber Onset and Far Field Morphology SVT Discriminators Clinical Summary [PDF 0.11MB] (EN)

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 More
100167396, 100167384, 100168022, 100167398, 100167399, 100168025, 100167340, 100167380, 100167451, 100170626, 100168192, 100170675, 100170659, 1001682 More
ARTEN600131456 - 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.

Performance of Chamber Onset and Far Field Morphology SVT Discriminators Clinical Summary

Products, 15 Total

  • 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
  • CDHFA600Q Neutrino NxTHF_ICD_JMRI_US
  • CDHFA800Q Neutrino NxTHF_ICD_JMRI_US
  • CDDRA800Q NeutrinoNxT DR_ICD_JMRI_US
See All

Performance of Chamber Onset and Far Field Morphology SVT Discriminators Clinical Summary

Reorder/Model Numbers, 15 Total

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

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