FDA Registration
Active
🇺🇸 United States
St. Jude Medical
Reg #: 3012179728
·
FEI: 3012179728
·
Expires 2026
Products
32
Proprietary Names
688
Establishment Types
3
Classifications
32
Registration Details
- Registration Name
- St. Jude Medical
- Registration Number
- 3012179728
- FEI Number
- 3012179728
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2305 Walnut Street
- City
- Roseville
- State
- MN
- ZIP
- 55113
- Country
- US
Regulatory Submissions
- 510(k) Number
- K243493
- PMA Number
- P120021
Owner / Operator
- Firm Name
- ABBOTT LABORATORIES
- Operator Number
- 1415939
- Address
- 100 ABBOTT PARK RD., D-03Q3, AP52-1
- City
- Abbott Park
- State
- IL
- Postal Code
- 60064
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2024-12-18 |
| Catheter, Electrode Recording, Or Probe, Electrode Recording | DRF | Class 2 | Cardiovascular | No | 2009-08-20 |
| Catheter, Intravascular Occluding, Temporary | MJN | Class 2 | Cardiovascular | No | 2017-02-17 |
| Transcatheter Septal Occluder | MLV | Class 3 | Unknown | No | 2016-10-31 |
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2022-11-02 |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | OAE | Class 3 | Unknown | No | 2023-05-19 |
| System, Imaging, Optical Coherence Tomography (Oct) | NQQ | Class 2 | Radiology | No | 2017-05-18 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2017-02-17 |
| Catheter, Intracardiac Mapping, High-Density Array | MTD | Class 2 | Cardiovascular | No | 2024-07-30 |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter | OAD | Class 3 | Unknown | No | 2020-03-24 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2012-10-12 |
| Occluder, Patent Ductus, Arteriosus | MAE | Class 3 | Unknown | No | 2015-09-11 |
| Electrode, Pacemaker, Temporary | LDF | Class 2 | Cardiovascular | No | 2007-12-11 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | Class 2 | Cardiovascular | No | 2007-12-11 |
| Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation | QZI | Class 3 | Unknown | No | 2025-12-22 |
| Device, Vascular, For Promoting Embolization | KRD | Class 2 | Cardiovascular | No | 2017-02-17 |
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 2008-02-13 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2017-02-17 |
| Heart-Valve, Mechanical | LWQ | Class 3 | Unknown | No | 2007-10-16 |
| Cardiac Ablation Percutaneous Catheter | LPB | Class 3 | Unknown | No | 2012-02-06 |
| Catheter, Ultrasound, Intravascular | OBJ | Class 2 | Cardiovascular | No | 2025-09-04 |
| Heart-Valve, Non-Allograft Tissue | LWR | Class 3 | Unknown | No | 2011-04-21 |
| Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only) | JOQ | Class 2 | Cardiovascular | No | 2010-06-04 |
| System, Appendage Closure, Left Atrial | NGV | Class 3 | Unknown | No | 2021-08-14 |
| Catheter, Steerable | DRA | Class 2 | Cardiovascular | No | 2007-12-11 |
| Ring, Annuloplasty | KRH | Class 2 | Cardiovascular | No | 2007-10-16 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2014-11-21 |
| Trocar | DRC | Class 2 | Cardiovascular | No | 2021-01-11 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2017-05-18 |
| System, Signal Isolation | DRJ | Class 1 | Cardiovascular | No | 2010-11-29 |
| Reprocessed Intravascular Ultrasound Catheter | OWQ | Class 2 | Cardiovascular | No | 2025-07-01 |
| Aortic Valve, Prosthesis, Percutaneously Delivered | NPT | Class 3 | Unknown | No | 2021-09-17 |
Proprietary Names
Agilis NxT Steerable Introducer Dual-Reach, Steerable Introducer
Agilis NxT, Steerable Introducer
AMPLATZER Sizing Balloon
Advisor FL Circular Mapping Catheter, Sensor Enabled
Reflexion Spiral Variable Radius Ca
WorkMate Claris System, Cable Kit
WorkMate Claris System, ECG Cable Set, Radiopaque
Radiotranslucent Leadwire
Kit ECG Cable Radio-Translucent 36in Brn
Mouse, PS2, Wired
WM Claris Additional Monitor Cable Kit
Cable Assy, Stim, EP4
Catheter Input Module 1-56
Cable Assy, IBP, Baxter Truwave
Cable Assy, IBP, Merit Meritrans
v.1.2.1 Onyx Scribe Upgrade Kit
Fiber Optic Cable - Duplex LC/LC
Power Supply Connector Adapter
WorkMate ImageSync Module
WM Claris CPU
Ferrite, Round Cable Snap-its, 200MHz-10
Kit WM Claris V1.1 Upgrade
WM Claris Z440 v.1.2 Upgrade Kit
Cable Assy, IBP, Namic Preceptors DT
WM Scribe Onyx v.1.2 Upgrade Kit
Media Conv, DB9 to Fiber SC
Cable Assy, IBP, Abbott Transpac IV
Cable Assy, IBP, Maxxim Cobe
SCU II Assembly 448 Channel
EP-4 Stimulator System 110V
USB Optical Scroll Mouse, Wired
v.1.2.1 Z440 Upgrade Kit
S-Video to VGA Signal Converter
Power Conditioner, 120 VAC, 1440 VA Medi
Cable Assy, IBP, Medex 960
SCU II Assembly 96 Channel
DVI to HDMI Adapter
LCD Dual Monitor Mount Kit
Reverse IEC Accessory Power Strip
WM Unity Review Module - 10 User License
Monitor, Touch Screen LCD, 19 Inch
Media Conv, SC Fiber to DB9
Cable Assy, IBP, Omedha DTXX
EP-WorkMate/EP-4 USB Keyboard
WorkMate Scribe Module 110V with Physio
USB Keyboard, Wired, English
DVI to DisplayPort Adapter
WM Claris Power Kit, 110
Power Conditioner, 120 VAC, 600 VA,
Cable Assy, IBP, Medex 860
WorkMate Claris System, Bed Rail Kit
Keyboard, PS2, Wired
2-port DVI splitter
Cable Equipotential
v.1.2.1 Z620 Upgrade Kit
WorkMate Claris System, System - Display Plus
WorkMate Claris System, Generic Stimulator Cable
WorkMate Scribe CPU
Ferrite round cable snap its 1 to 300MHz
WM Unity Review Mod - Sgl User License
WorkMate Scribe Module
Monitor, LCD, 16:9 1920x1080 Resolution
WorkMate Unity DICOM Module
4 Outlet Reverse IEC Accessory Power Str
Cable Assy, IBP, Utah Deltran
WM Claris Z620 v.1.2 Upgrade Kit
Cable Assy, IBP, Medex 950
WorkMate Claris System Display Workstation
EP-4 Cardiac Stimulator, Cardiac Stimulator Cable
incorrect Power Cord, C-18 to C-7, 250V
Stim Cable, WorkMate Claris Generic
EP-4 Touch Screen Computer
Additional Monitor Stand Kit
WorkMate Claris System, Amplifier
WorkMate Claris PM Kit DWG 90169898
WorkMate Claris System, ECG Cable Set, Radiolucent
EP-4 Cardiac Stimulator
WorkMate Claris System, CI Module 2
WorkMate Scribe Module, Software Upgrade Kit
WorkMate Claris System, Bottom Shelf Computer Bench
WorkMate Claris System, Module Cart
WorkMate Unity HL7 Module
Catheter Input Module 57-120
WM Unity Review Module - Site License
WorkMate Claris System, Cart
Fiber Optic Cable - Duplex LC/LC 30m
Cable, Serial, 3 ft DB9
Power Supply, 5V MG with 2.5MM I.D.
DMS59 to Dual DVI SPlitter Video Cable
Cable, COAX
WorkMate Claris OS Patch SW Kit
WorkMate Claris Bed Rail Kit
WorkMate Claris System, Software Upgrade Kit
WorkMate Claris System, Bed Bracket Assembly
WorkMate Claris System, Display Plus Amplifier
WorkMate Claris System, Preventative Maintenance Kit
WorkMate Claris System, Invasive Blood Pressure Cable
WorkMate Claris System, Printer
WorkMate Claris System, Grounding Cable
WorkMate Claris System, CI Module 1
WorkMate Claris System
WorkMate Claris System, Bracket Bottom Shelf Computer Bench
WorkMate Claris System, ECG Cable
WorkMate Scribe Module, Display Workstation
Percutaneous Catheter Introducer & Removable Hemo
Hemostasis Valve Adapter
Fast-Cath Hemostasis Introducer
Fast-Cath Trio Hemostasis Introducer
TactiFlex Sensor Enabled, Ablation Catheter - A-TFSE-DD-X
TactiFlex Sensor Enabled, Ablation Catheter - A-TFSE-JJ-X
TactiFlex Sensor Enabled Ablation Catheter - A-TFSE-FJ
TactiFlex Sensor Enabled Ablation Catheter - A-TFSE-D
TactiFlex Sensor Enabled Ablation Catheter - A-TFSE-J
Ampere Generator Kit
TactiFlex Sensor Enabled Ablation Catheter - A-TFSE-DD
TactiFlex Sensor Enabled Ablation Catheter - A-TFSE-DF
TactiFlex Sensor Enabled Ablation Catheter - A-TFSE-FF
TactiFlex Sensor Enabled, Ablation Catheter - A-TFSE-FF-X
TactiFlex Sensor Enabled Ablation Catheter - A-TFSE-F
Unified Connector RF SE Cable, Radiofrequency Cable
TactiSys Quartz, TactiFlex Radiofrequency Cable, TSQ-RF-TFSE-CBL
TactiFlex Sensor Enabled Ablation Catheter - A-TFSE-JJ
TactiFlex Sensor Enabled, Ablation Catheter - A-TFSE-FJ-X
TactiFlex Sensor Enabled, Ablation Catheter - A-TFSE-J-X
Ampere Remote Control
Ampere Generator
TactiFlex Sensor Enabled, Ablation Catheter - A-TFSE-F-X
TactiFlex Sensor Enabled, Ablation Catheter - A-TFSE-DF-X
TactiFlex Sensor Enabled, Ablation Catheter - A-TFSE-D-X
TactiSys Quartz Equipment
TactiCath Contact Force Ablation Catheter, Sensor Enabled
Ampere Generator
Ampere Generator Fiber Cord Assembly Remote
ILUMIEN System
ILUMIEN Guided Therapy System
ILUMIEN Therapy Guidance System
Amplatzer TorqVue LP Delivery System
Inquiry AFocus II
Inquiry
Inquiry AFocus
Advisor HD Grid X, Sensor Enabled High Density Mapping Catheter
Advisor HD Grid X Mapping Catheter, Sensor Enabled
EnSite LiveView Dynamic Display Software License
EnSite Precision Software Installation v2.6
EnSite Precision Software Upgrade v2.7.1
EnSite Precision Software Installation v.2.7 H702701
EnSite Precision Surface Electrode Kit EN0020-p
EnSite Precision System Software Upgrade v.2.6.1, H702602
EnSite X EP System Amplifier
EnSite X EP System EnSite Echo Module Temporary Software License
EnSite X EP System
EnSite X EP System RL ECG Electrode
EnSite X EP System Upgrade Kit
EnSite X EP System Cable Kit
EnSite X EP System Display Workstation
EnSite X EP System EnSite Echo Module Software License
EnSite X EP System EnSite X Dual Monitor Software License
EnSite X EP System, Software Upgrade
EnSite X EP System Advisor HD Grid X Mapping Catheter, Sensor Enabled, Software License
Safire TX Ablation Catheter
Safire Duo Ablation Catheter, MediGuide Enabled
Therapy Cool Path Duo Ablation Catheter
Therapy Cool Flex Ablation Catheter
Ampere Generator Kit
Cool Path Duo Ablation Catheter, MediGuide Enabled
Therapy Dual-8 Ablation Catheter
Therapy Cool Path Ablation Catheter
Contact Therapy Cool Path Duo Ablation Catheter
Ampere Generator Generator Accessories
Ampere Remote Control
Cool Point Irrigation Pump
Therapy Ablation Catheter
FemoStop Gold
AMPLATZER TorqVue 45x45 Delivery Sheath 80 cm
CPS Direct SL Outer Catheter-410190
Response with Lumen
CPS Aim SL Slittable Inner Catheter
Models DS2N021-59, DS2N021-65, DS2N022-59, DS2N022-65, DS2N023-59, DS2N023-65, DS2N024-65, DS2N025-65
ILUMIEN OPTIS System and Accessories
EnSite X EP System, AutoMark Index Temporary, Software License, ENSITE-D-AMI-01
EnSite X EP System, AutoMark Index, Software License, ENSITE-AMI-01
Amplatzer TorqVue 2 Delivery Sheath
Inquiry Optima PLUS
Inquiry Optima
Inquiry Afocus
DS2C022, DS2C023, DS2C024, DS2C025, DS2C026, DS2C027, DS2C028,DS2C029, DS2C030
CPS Direct Universal Slittable Outer Catheter, Models DS2C018, DS2C019, DS2C020, DS2C021
Amplatzer Muscular VSD Occluder
Fast-Cath Transseptal Guiding Introducer
Swartz Braided Transseptal Guiding Introducer
Fast-Cath Guiding Introducer
Fast-Cath Transseptal Guiding Introducer
Fast-Cath Hemostasis Introducer
Fast-Cath Trio Hemostasis Introducer
Fast-Cath Duo Hemostasis Introducer
ECG Adapter
Pacel Flow Directed Pacing Catheter
Disposable Patient Cables
SJM Adapter
Cable Connectors
SJM Patient Cable 401758,401759,401760
SJM Threshold Cable 401748
SJM Epicardial Cable 401777, 401778
Abbott Medical Threshold Cable
Abbott Medical Epicardial Cable
Abbott Medical Patient Cable
Agilis NxT Steerable Introducer
Agilis NxT
Current PFA Radiolucent ECG Lead Set
Current PFA ECG Trunk Cable
Volt PFA Kit
Current PFA Catheter Input Module
Current PFA Unified Cable
Current PFA Generator Cart
Current PFA Recording System Connect Cable
Volt PFA Catheter, Sensor Enabled
Current PFA Radiopaque ECG Lead Set
Current PFA Generator
Current PFA Generator Software Upgrade
Amplatzer Vascular Plug II (AVP II)
Amplatzer Cardiac Plug (ACP)
Amplatzer Duct Occluder
Amplatzer Duct Occluder II
Amplatzer Piccolo Occluder
Amulet Steerable Delivery Sheath
Amplatzer TorqVue LP Catheter
Response Electrophysiology Catheter
Supreme Electrophysiology Catheter
Inquiry AFocus II Diagnostic Catheter
Response Electrophysiology Catheter
Epicardial Catheter System
MediGuide Enabled Livewire Steerable Electrophysiology Catheter
Livewire Steerable Electrophysiology Catheter
Response Electrophysiology Catheter with Lumen
Telesheath Guiding Introducer
Advisor VL Circular Mapping Catheter, Sensor Enabled
Ensite Velocity Software Upgrade Kit, v5.2.1
Ensite Velocity System Siemens RecordConnect
Ensite Precision Software Installation v.2.1
Ensite Precision Power Supply Kit
Ensite Velcity System Display Workstation Kit
Ensite Velocity System Amplifier Kit
Remote Monitor Stand
Ensite Precision Field Frame Cable,
Ensite Velocity Amplifier and Display Workstation
Ensite Velocity Kit, GenConnect, Stockert, NST
TactiCath Ablation Catheter, Sensor Enabled Software Installation
Ensite Amplifier and Display Workstation, EE3000
TactiCath Ablation Catheter, Sensor Enabled Catheter Catalog Installation, v.1
GenConnect
Ensite Precision Software Installation v.2.1 30 Day Trial
Ensite Velocity System GenConnect Kit IBI
Advisor HD Grid Mapping Catheter, Sensor Enbled Software Installation, H702519
Ensite Precision Field Frame Bracket, H702472
Ensite System RecordConnect RFB
Ensite Velocity Remote Monitor Stand
Advisor HD/VL Mapping Catheter, Catheter Catalog Installation Sensor Enabled, H702532
Ensite Precision Software Installation
Power Cord, Compatible with St. Jude Medical Electrophysiology Products
Ensite AutoMap Module v.1, H702498
Ensite Precision Patient Reference Sensor
Printer
Ensite Velocity System RecordConnect Kit Universal
Ensite Velocity Display Workstation
Ensite Velocity Software Upgrade Kit, v5.1
Ensite Velocity System CathLink Module
Ensite AutoMap Module v.1 30 Day Trial, H702498-T
Ensite Velocity System GenConnect (GenConnect interface to Stockert generator.)
Ensite Velocity Amplifier Cart
Ensite Velocity Amplifier and DWS
Ensite Velocity System EP-WorkMate RecordConnect
EnSite Precision Surface Electrode Kit, PRCN-SEK-A
Ensite Derexi Module v.1.3.1, H702502
Ensite Velocity DWS HDD
TactiCath Ablation Catheter, Sensor Enabled Software Installation 30 Day Trial
Ensite Velocity Display Workstation (DWS)
Ensite Velocity System Workstation
EnSite Precision Surface Electrode Kit
Ensite Precision Link, Sensor Enabled Link
Ensite Velocity System Remote Monitor Stand
AutoMark Installation Kit, H702499-HW
Ensite Velocity System GenConnect (GenConnect interface to T-series generator.)
Ensite System GenConnect (GenConnect interface to Atakr generator.)
Ensite Velocity CathLink Module
Ensite System GenConnect (GenConnect Interface to EPT generator.)
Ensite Precision Software Installation v.2 30 Day Trial
Ensite Precision Bedrail Mount Kit, H702474
Ensite Velocity System GenConnect (GenConnect interface to Stockert SmartAblate generator.)
Ensite Precision Field Frame Storage Bracket
EnSite Precision Patient Reference Sensor SURF-ELEC-2PRS
Ensite System GenConnect (GenConnect interface to Atakr generator.) RFB
Ensite System RecordConnect (RecordConnect interface to Bard Stamp recording system.)
Ensite Velocity RecordConnect For Use With WorkMate Claris System
EnSite Precision Module, Sensor Enabled Module
Ensite Velocity RecordConnect
Ensite Velocity System Equipotential Cable
Ensite Velocity EP-WorkMate Record Connect
Ensite Precision Field Frame, H702469
AutoMark Software Installation v.1, H702499
Ensite Velocity ArrayLink Module
Ensite Precision Software Installation v.2.2 30 Day Trial
Ensite Velocity System Workstation Accessory Kit
Ensite System RecordConnect (RecordConnect interface to Bard Stamp recording system.) RFB
Ensite Velocity System Cable Accessory Kit
Ensite Velocity Amplifier
Ensite Fusion Software Upgrade Kit v.7.1, H702506
Ensite Contact Force Module Software Installation, H702500
Record Connect
Ensite Velocity Cable Assembly Kit, T Series
Ensite Velocity Workstation Cart
FlexAbility Ablation Catheter, Sensor Enabled Software Installation
Ensite Velocity System Amplifier Cart
Ensite Contact Force Module Software Installation v.2 30 Day License, H702500-T
Ensite Velcity System GenConnect (GenConnect interface to Stockert generator.)
EnSite System Reference Electrode, SYS-REF-V1
Ensite Precision Field Frame Bracket, H702472-E
Advisor FL Mapping Catheter, Sensor Enabled Software Installation, H702507
Ensite Contact Force Module Software Installation, v.2, H702500
Ensite Velocity System RecordConnect
Ensite Velocity System GE CardioLab RecordConnect
Ensite Precision Software Installation v.2.2
EnSite Velocity Surface Electrode Kit Large, 5 Pack EN0010-10000331
Ensite Courier Software Installation v.3, H702501
Ensite Velocity Bard Clearsign RecordConnect
Ensite Velocity System GenConnect
Ensite Contact Force Module Installation Kit, H702500-HW
Ensite System RecordConnect
Ensite Verismo Software Upgrade Kit v.2.1
Ensite Velocity Sytstem Workstation
Ensite Courier Software Installation v.3 30 Day Trial, H702501-T
Ensite Velocity Software Upgrade Kit, v5.2
Ensite Velocity System Workstation Cart
Ensite Velocity System RecordConnect (RecordConnect interface to Bard Clearsign recording system.)
Ensite Display Workstation, EE3000
Ensite Velocity System Monitor 24"
Ensite MediGuide Interface Module Software Installation v.1.1, H702503
Ensite Velocity System DWS Kit
Ensite System GenConnect (GenConnect Interface to EPT generator.) RFB
Ensite Velocity NavLink Module
Ensite Velocity Display Workstation DWS Kit
EnSite Precision Adjustable Field Frame Bracket
EnSite CathLink Module, Catheter Input Module
EnSite GenConnect Module, Generator Connector
EnSite RecordConnect Module, Recording System Connector
EnSite NavLink Module, Surface Electrode Connector
EnSite ArrayLink Module, Catheter Input Module
Agilis NxT Steerable Introducer
Sensor Enabled Diagnostic Connection Cable
Reflexion Spiral EP Extension Adaptor
EnSite X EP System Catheter Connector Cable, D-ENS-AVSE-5-CBL
EnSite X EP System Catheter Connector Cable, D-ENS-SUP-D-CBL
Response Electrophysiology Extension Cable
Supreme Electrophysiology Cable
EnSite X EP System Catheter Connector Cable, D-ENS-INQ-OD-CBL
EnSite X EP System Catheter Connector Cable, D-ENS-AVSE-6-CBL
Electrophysiology Extension Cable
EnSite X EP System Catheter Connector Cable, D-ENS-L/R-HOD-CBL
EnSite X EP System Catheter Connector Cable, D-ENS-INQ-Q-CBL
EnSite X EP System Catheter Connector Cable, D-ENS-SUP-Q-CBL
EnSite X EP System Catheter Connector Cable, D-ENS-SUP-DDY-CBL
EnSite X EP System Catheter Connector Cable, D-ENS-L/R-BQ-CBL
EnSite X EP System Catheter Connector Cable, D-ENS-INQ-DD-CBL
EnSite X EP System Catheter Connector Cable, D-ENS-SUP-H-CBL
EnSite X EP System Catheter Connector Cable, D-ENS-L/R-DDY-CBL
Electrophysiology Cable
EnSite X EP System, Catheter Connector Cable, A-ENS-MAGEXT-CBL
Sensor Enabled Cable, Diagnostic Catheter Cable
EnSite X EP System Catheter Connector Cable, ICE-VFSE-2D-CBL
EnSite X EP System Catheter Connector Cable, D-ENS-AVHDX-CBL
Amplatzer TorqVue Delivery System
EnSite X EP System Display Workstation, ENSITE-R-DWS-01
EnSite X EP System IC Output Cable, ENSITE-WM64-60-01
EnSite X EP System Bedrail Mount, ENSITE-RAILMNT-01
EnSite X EP System Radio-lucent ECG Lead Set, ENSITE-ECGRL-01
EnSite X EP System Patient Reference Sensor, ENSITE-PRSFRNT-01
EnSite X EP System Monitor Pole, ENSITE-MONPOLE-01
EnSite X EP System Field Frame, ENSITE-R-FF-01
EnSite X EP System Amplifier Power Module, ENSITE-AMP-EPM-01
EnSite X EP System IC Output Cable, ENSITE-WM64-144-01
EnSite X EP System EnSite Omnipolar Technology Data Export, ENSITE-OTEXPORT-01
EnSite X EP System IC Output Cable, ENSITE-WM56-144-01
EnSite X EP System Connect Cable, ENSITE-ACBL-60-01
EnSite X EP System Display Workstation, ENSITE-DWS-1.1
EnSite X EP System ECG Cable, ENSITE-CECG-144-01
EnSite X EP System Radio-opaque ECG Lead Set, ENSITE-ECGRO-01
EnSite X EP System Software Upgrade, ENSITE-SW-1.1.2
EnSite X EP System Patient Reference Sensor, ENSITE-PRSBACK-01
EnSite X EP System Contact Force Software License, ENSITE-CF-01
EnSite Fixed Field Frame Bracket, ENSITE-FF-BRCKT-01
EnSite X EP System Triple Monitor Mount, ENSITE-TMMK-01
EnSite X EP System EnSite LiveView Dynamic Display Demo, ENSITE-D-LV-01
EnSite X EP System Wave Speed Map, ENSITE-WS-01
EnSite X EP System EnSite LiveView Dynamic Display, ENSITE-LV-01
EnSite X EP System IC Output Cable, ENSITE-WM56-60-01
EnSite X EP System Amplifier Cart, ENSITE-AMPCART3-01
EnSite X EP System Single Monitor Mount, ENSITE-SMMK-01
EnSite X EP System Catheter Input Module, ENSITE-CIM-80-01
EnSite X EP System Recording System IC Output Cable, ENSITE-CR-56-01
EnSite X EP System EnSite Omnipolar Technology, ENSITE-OT-01
EnSite X EP System ECG Cable, ENSITE-CECG-60-01
EnSite X EP System Amplifier Cart, ENSITE-AMPCART1-01
EnSite X EP System Amplifier, ENSITE-R-AMP-01
EnSite X EP System ECG Output Module, ENSITE-ECGOUT-01
EnSite X EP System Software Upgrade, ENSITE-SW-1.1
EnSite X EP System SurfaceLink Module, ENSITE-SRFLNK-01
EnSite X EP System Display Workstation, ENSITE-DWS-01
EnSite X EP System Field Frame, ENSITE-FF-01
EnSite X EP System Catheter Input Module, ENSITE-CIM-20-01
EnSite X EP System Connect Cable, ENSITE-ACBL-160-01
EnSite X EP System Field Frame Cable, ENSITE-FF-4.5C-01
EnSite X EP System Amplifier, ENSITE-R-AMP-02
EnSite X EP System Contact Force Software License, ENSITE-D-CF-01
EnSite X EP System Dual Monitor Mount, ENSITE-DMMK-01
EnSite X EP System Live Export Software License, ENSITE-LE-01
EnSite X EP System Amplifier, ENSITE-AMP-02
EnSite X EP System Amplifier, ENSITE-AMP-01
EnSite X EP System Remote Monitor Stand, ENSITE-RMS-01
EnSite X EP System Surface Electrode Kit, ENSITE-SEK-5-01
EnSite Adjustable Field Frame Bracket, ENSITE-FF-ABRKT-01
EnSite X EP System Recording System IC Output Cable, ENSITE-CR-64-01
EnSite X EP System Software Upgrade, ENSITE-SW-1.1.1
EnSite X EP System EnSite Omnipolar Technology Demo, ENSITE-D-OT-01
EnSite X EP System Field Frame Cable, ENSITE-FF-3MC-01
EnSite X EP System Wave Speed Map Demo, ENSITE-D-WS-01
EnSite X EP System Display Workstation Cart, ENSITE-DWSCART-01
EnSite X EP System Display Workstation, ENSITE-R-DWS-1.1
Amplatzer Sizing Plate
ENSITE-DWSCART-01 EnSite X EP System Display Workstation Cart
ENSITE-D-LV-01 EnSite X EP System EnSite LiveView Dynamic Display Demo Software License
ENSITE-SEK-5-01 EnSite X EP System Surface Electrode Kit
ENSITE-DMMK-01 EnSite X EP System Dual Monitor Mount
ENSITE-RAILMNT-01 EnSite X EP System Bedrail Mount
ENSITE-D-WS-01 EnSite X EP System Wave Speed Map Demo Software License
ENSITE-TF-02 EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled Software License
ENSITE-FLEX-01 EnSite X EP System, VoXel Flex, Software License
ENSITE-DWS-01 EnSite X EP System Display Workstation
ENSITE-D-CF-01 EnSite X EP System Contact Force Software License
ENSITE-SW-2.1 EnSite X EP System Software Upgrade
ENSITE-D-AMD-01 EnSite X EP System, AutoMark Distance Demo, Software License
ENSITE-DWS-1.1 EnSite X EP System Display Workstation
ENSITE-LS-01 EnSite X EP System, LiveSync, Software License
ENSITE-D-IMP-01 EnSite X EP System, Averaged Impedance Drop Demo, Software License
ENSITE-IMP-01 EnSite X EP System, Averaged Impedance Drop, Software License
ENSITE-D-OT-01 EnSite X EP System EnSite Omnipolar Technology Demo Software License
ENSITE-AAF-01 EnSite X Amplifier Air Filter
ENSITE-CL-01 EnSite X EP System EnSite Cloud Software License
ENSITE-FF-BRCKT-01 EnSite Fixed Field Frame Bracket
ENSITE-CIM-80-01 EnSite X EP System Catheter Input Module
ENSITE-R-AMP-02 EnSite X EP System Amplifier
ENSITE-AMP-EPM-01 EnSite X EP System Amplifier Power Module
ENSITE-DWS-2.1 EnSite X EP System Display Workstation
ENSITE-OTAC-01 EnSite X EP System OTA Certificate Software License
ENSITE-ACBL-60-01 EnSite X EP System Connect Cable
ENSITE-SW-1.2 EnSite X EP System Software Upgrade
ENSITE-CR-56-01 EnSite X EP System Recording System IC Output Cable
ENSITE-WM64-144-01 EnSite X EP System IC Output Cable
ENSITE-WM64-60-01 EnSite X EP System IC Output Cable
ENSITE-AM-2 EnSite X EP System Advanced Mapping Software License
ENSITE-SMMK-01 EnSite X EP System Single Monitor Mount
ENSITE-FF-01 EnSite X EP System Field Frame
ENSITE-AMPCART1-01 EnSite X EP System Amplifier Cart
ENSITE-OTEXPORT-01 EnSite X EP System EnSite Omnipolar Technology Data Export Software License
ENSITE-TFM-02 EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade
ENSITE-FWV-01 EnSite X EP System EnSite PFA Catheter Visualization, Software License
ENSITE-AMP-02 EnSite X EP System Amplifier
ENSITE-SW-3.2 EnSite X EP System Software Upgrade v3.2
ENSITE-SRFLNK-01 EnSite X EP System SurfaceLink Module
ENSITE-CR-64-01 EnSite X EP System Recording System IC Output Cable
ENSITE-SYSTEM-111 EnSite X EP System
ENSITE-CIM-20-01 EnSite X EP System Catheter Input Module
ENSITE-ECGRO-01 EnSite X EP System Radio-opaque ECG Lead set
ENSITE-CF-01 EnSite X EP System Contact Force Software License
ENSITE-SW-1.1 EnSite X EP System Software Upgrade
ENSITE-FF-ABRKT-01 EnSite Adjustable Field Frame Bracket
ENSITE-RMS-01 EnSite X EP System Remote Monitor Stand
ENSITE-ECGRL-01 EnSite X EP System Radio-lucent ECG Lead set
ENSITE-D-LS-01 EnSite X EP System, LiveSync Demo, Software License
ENSITE-AMD-01 EnSite X EP System, AutoMark Distance, Software License
ENSITE-ACBL-160-01 EnSite X EP System Connect Cable
ENSITE-AMP-01 EnSite X EP System Amplifier
ENSITE-LE-01 EnSite X EP System Live Export Software License
ENSITE-OT-01 EnSite X EP System EnSite Omnipolar Technology Software License
ENSITE-CECG-60-01 EnSite X EP System ECG Cable
ENSITE-SYSTEM-201 EnSite X EP System
ENSITE-R-DWS-1.1 EnSite X EP System Display WorkStation
ENSITE-SW-2 EnSite X EP System Software Upgrade
ENSITE-SW-1.1.2 EnSite X EP System, Software Upgrade
ENSITE-R-FF-01 EnSite X EP System Field Frame
ENSITE-WM56-144-01 EnSite X EP System IC Output Cable
ENSITE-D-FLEX-01 EnSite X EP System, VoXel Flex Demo, Software License
ENSITE-CECG-144-01 EnSite X EP System ECG Cable
ENSITE-WS-01 EnSite X EP System Wave Speed Map Software License
ENSITE-PRSFRNT-01 EnSite X EP System Patient Reference Sensor
ENSITE-TFM-3.2 EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software Upgrade
ENSITE-SW-1.1.1 EnSite X EP System Software Upgrade
ENSITE-R-DWS-2.1 EnSite X EP System Display Workstation
ENSITE-MONPOLE-01 EnSite X EP System Monitor Pole
ENSITE-D-AM-2 EnSite X EP System Advanced Mapping Demo Software License
ENSITE-TMMK-01 EnSite X EP System Triple Monitor Mount Kit
ENSITE-R-DWS-01 EnSite X EP System Display Workstation
ENSITE-PRSBACK-01 EnSite X EP System Patient Reference Sensor
ENSITE-TFM-03 EnSite X EP System, TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade
ENSITE-FF-3MC-01 EnSite X EP System Field Frame Cable
ENSITE-R-AMP-01 EnSite X EP System Amplifier
ENSITE-LV-01 EnSite X Ep System EnSite LiveView Dynamic Display Software License
ENSITE-ECGOUT-01 EnSite X EP System ECG Output Module
ENSITE-SW-03 EnSite X EP System Software Upgrade
ENSITE-WM56-60-01 EnSite X EP System IC Output Cable
ENSITE-ECGRL-01 EnSite X EP System, Radio-lucent ECG Lead Set
ENSITE-D-FWV-01 EnSite X EP System, EnSite PFA Catheter Visualization Temporary, Software License
ENSITE-FF-4.5C-01 EnSite X EP System Field Frame Cable
ENSITE-AMPCART3-01 EnSite X EP System Amplifier Cart
EnSite X EP System Software Upgrade
Masters Series HP Valved Graft with Gelweave Valsalva Technology (VAVGJ)
Masters Series Mechanical Heart Valve with Expanded Polyester Sewing Cuff (Aortic)
Masters Series Aortic Valved Graft with Hemashield Graft Technology (CAVGJ)
Masters Series Mechanical Heart Valve with Expanded Polyester Sewing Cuff (Mitral)
Masters Series Mechanical Heart Valve (Aortic)
Masters Series Mechanical Heart Valve with Hemodynamic Plus (HP) Sewing Cuff (Mitral)
SJM Masters Series Mechanical Heart Valve
Masters Series Mechanical Heart Valve (Mitral)
Masters Series Mechanical Heart Valve with Expanded Hemodynamic Plus (HP) Sewing Cuff (Aortic)
SJM Masters Series Mechanical Heart Valve Mitral Expanded Hemodynamic Plus (HP)
Regent Mechanical Heart Valve
Masters Series Mechanical Heart Valve with PTFE Sewing Cuff (Aortic)
Masters Series Mechanical Heart Valve with Hemodynamic Plus (HP) Sewing Cuff (Aortic)
Masters Series Mechanical Heart Valve with PTFE Sewing Cuff (Mitral)
Regent Mechanical Heart Valve (FlexCuff)
SJM Masters Series Mechanical Heart Valve Aortic Expanded PTFE Cuff
FlexAbility Ablation Catheter
Sensor Enabled Ablation Connection Cable
FlexAbility Ablation Catheter, Sensor Enabled
Safire BLU Duo Ablation Catheter
IBI 1500T9-CP V1.6 Cardiac Ablation Generator
Ampere Generator Accessories
Ampere Footswitch
ViewFlex Xtra ICE Catheter
ViewFlex X ICE Catheter, Sensor Enabled
Trifecta Valve with Glide Technology (Trifecta GT)
Trifecta Bioprosthetic Heart Valve
EP-4 Cardiac Stimulator, Keyboard
EP-4 Cardiac Stimulator, Cardiac Stimulator
EP-4 Cardiac Stimulator, Touch Screen Computer
CPS Aim Universal Slittable Inner Catheter, Models DS2N026-59, DS2N027-59, DS2N028-59, DS2N026-65, DS2N027-65
CPS Aim Universal Slittable Inner Catheter, Models DS2N028-65, DS2N029-65, DS2N030-65
Bedrail Clamp- 100007639
EnSite Velocity Stockert GenConnect (Refurb) - 100047843
EnSite X EP System Contact Force Software License, ENSITE-D-CFLF-01
EnSite X EP System Radio-lucent ECG Lead Set, ENSITE-ECGRL-I-01
Power Kit OUS-H702505
EnSite X EP System ECG Output Module, ENSITE-ECGOUT-I-01
TactiCath Ablation Catheter, Sensor Enabled, Catheter Catalog Installation, v.1 - H702518
EnSite X EP System Contact Force Software License, ENSITE-CFLF-01
EnSite X EP System SurfaceLink Module, ENSITE-SRFLNK-I-01
Recorder Interconnect Kit, Bard V5 - 75-04629-002
Ensite Velocity Intl Power Kit - 100019046
EnSite Velocity Ablation Cable Kit, Stockert - 75-04469-003
EnSite System (RFB GenConnect interface to Atakr generator) - 100039379
EnSite Velocity Ablation Cable Kit, IFI, T9 - 75-05392-001
EnSite Verismo, Software Installation, v.2.x - H00001
EnSite X EP System Radio-opaque ECG Lead Set, ENSITE-ECGRO-I-01
EnSite System GenConnect (GenConnect interface to EPT generator) - 100038592
EnSite Velocity Amplifier Cart - H710002
EnSite Precision Module - Hardware- H702473
TactiCath Ablation Catheter, Sensor Enabled, Software Installation, 30 Day Trial - H702517-T
EnSite X EP System TactiFlex Ablation Catheter Sensor Enabled Software Upgrade, ENSITE-TFM-01
RecordConnect (Universal Refurb) - 100040093
EnSite X EP System TactiFlex Ablation Catheter Sensor Enabled Software License, ENSITE-TF-01
WorkMate Claris System, Power Kit, China
WorkMate Scribe Module
ENSITE-GENECG-OUS EnSite X EP System PFA ECG Signal Splitter
EnSite X EP System, PFA Index, Software License (ENSITE-PI-01)
EnSite X EP System, TactiFlex Duo Ablation Catheter, Sensor Enabled Temporary, Software License (ENSITE-D-FOCAL-01)
EnSite X EP System, EnSite AI Geo Temporary Software License, ENSITE-D-AGL-01
EnSite X EP System, EnSite AI Geo Software License, ENSITE-AG-01
EnSite X EP System, PFA Index Temporary, Software License (ENSITE-D-PI-01 )
EnSite X EP System, TactiFlex Duo Ablation Catheter, Sensor Enabled, Software License (ENSITE-FOCAL-01)
AMPLATZER Vascular Plug 4
Pacel Bipolar Pacing Catheter
CPS Direct SL II Slittable Outer Catheter
DS2C001, DS2C002, DS2C003, DS2C004, DS2C005, DS2C006, DS2C011, DS2C012, DS2C013, DS2C014, DS2C015
CPS Universal II Slitter Model DS2A004
CPS Universal Slitter Model DS2A003
Rigid Saddle Ring
SJM Rigid Saddle Ring
Cardioverter Cable
Advisor FL Circular Mapping Catheter, Sensor Enabled, D-AVSE-DF10-F15
Advisor FL Circular Mapping Catheter, Sensor Enabled, D-AVSE-D10-F20
Advisor VL Circular Mapping Catheter, Sensor Enabled, D-AVSE-DF10-V1525
Advisor VL Circular Mapping Catheter, Sensor Enabled, D-AVSE-DF20-V1525
Advisor HD Grid High Density Mapping Catheter, Sensor Enabled, D-AVHD-DF16
Advisor FL Circular Mapping Catheter, Sensor Enabled, D-AVSE-D10-F15
Advisor VL Circular Mapping Catheter, Sensor Enabled, D-AVSE-D20-V1525
Advisor VL Circular Mapping Catheter, Sensor Enabled, D-AVSE-D10-V1525
Advisor FL Circular Mapping Catheter, Sensor Enabled, D-AVSE-DF10-F20
CPS Excel MediGuide Enabled Guidewire, Model DS2M033, DS2M027, DS2M028, DS2M029, DS2M030
PFA-GEN-OVERLAY-F Current PFA Overlay
A-VOLT-01 Volt PFA Catheter, Sensor Enabled
PFA-TSQ-CBL Current PFA TactiSys Connect Cable
TactiFlex Duo Sensor Enabled Ablation Catheter
PFA-AMP-RETURN-CBL Current PFA Ampere Return Electrode Cable
PFA-GEN-OVERLAY Current PFA Overlay
PFA-GEN-V110 Current PFA Generator Software Upgrade
CPS Direct SL II Slittable Outer Catheter Models - DS2C007, DS2C017
Advisor HD Grid Mapping Catheter, Sensor Enabled
BRK XS Series Transseptal Needle G407211
BRK XS Series Transseptal Needle G407208
BRK-1 XS Series Transseptal Needle G407209
BRK-1 Transseptal Needle 407201
BRK XS Series Transseptal Needle G407210
BRK Transseptal Needle 407205
BRK-1 XS Series Transseptal Needle G407212
BRK-1 XS Series Transseptal Needle G407216
BRK Transseptal Needle 407206
BRK Transseptal Needle 407200
BRK-1 Transseptal Needle 407207
BRK Transseptal Needle G407215
Dragonfly OPTIS Imaging Catheter
OPTIS Integrated System and Accessories
Dragonfly OPTIS Imaging Catheter Kit
SJM Tailor Annuloplasty Band
Ampere RF Ablation Generator
Therapy Ablation Catheter
Grounding Cable 1710
Cool Point Irrigation Pump
Cool Point Tubing Set
Cool Point Irrigation Pump Pressure Alarm Adapter Cable
Electrophysiology Cable 1779
ENSITE-R-SYS-04 EnSite X EP System
ENSITE-SYSTEM-04 EnSite X EP System
ENSITE-D-ADASLA-01 ADAS 3D LA License Temporary Software License
ENSITE-ADASLV-01 ADAS 3D LV License Software License
ENSITE-OTAC-02 EnSite X EP System OTA Certificate Software License
ENSITE-SW-3.1 EnSite X EP System, Software Upgrade
ENSITE-TFM-3.1 EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software Upgrade
ENSITE-DWS-3.1 EnSite X EP System, Display Workstation
ENSITE-SYSTEM-3.1 EnSite X EP System
ENSITE-FWV-02 EnSite X EP System, EnSite PFA Catheter Visualization Software License
ENSITE-GENECG-NAM EnSite X EP System PFA ECG Signal Splitter
ENSITE-HDGX-01 EnSite X EP System Advisor HD Grid X Mapping Catheter, Sensor Enabled, Software License
ENSITE-D-ADASLV-01 ADAS 3D LV License Temporary Software License
ENSITE-R-DWS-3.1 EnSite X EP System, Display Workstation
ENSITE-R-SYS-3.1 EnSite X EP System
ENSITE-D-FWV-03 EnSite X EP System EnSite PFA Catheter Visualization Temporary Software License
ENSITE-R-DWS-04 EnSite X EP System Display Workstation
ENSITE-D-FWV-02 EnSite X EP System EnSite PFA Catheter Visualization Temporary Software License
ENSITE-ADAS-01 ADAS 3D Base License Software License
ENSITE-SW-3.1.1 EnSite X EP System Software Upgrade
ENSITE-FWV-03 EnSite X EP System EnSite PFA Catheter Visualization Software License
ENSITE-OTAC-03 EnSite X EP System OTA Certificate Software License
ENSITE-PFAGEN-01 EnSite X EP System PFA Generator Connect Cable
ENSITE-ADASLA-01 ADAS 3D LA License Software License
ENSITE-DWS-04 EnSite X EP System Display Workstation
AMPLATZER Vascular Plug - II ES
ViewFlex Catheter Interface Module
Safire Bi-Directional Catheter
Livewire TC Ablation Catheter
Safire Catheter Extension Cable
Seguin Annuloplasty Ring for Mitral Valve Repair
IBI-1100 Bi-Directional Steerable Electrophysiology Catheter System
Inquiry Steerable Diagnostic Catheter
Amplatzer TorqVue Exchange System
CPS 4F Slitter Model DS2A000, CPS Valve Bypass Tool (Aim SL) Model DS2A002
ViewFlex Xtra ICE Catheter D087031
SJM Threshold Cable
SJM Patient Cable
Attune Flexible Adjustable Annuloplasty Ring
Amplatzer Vascular Plug (AVP)
Amplatzer Vascular Plug
Inquiry Luma-Cath
Advisor HD Grid Sensor Enabled, High Density Mapping Catheter
ViewFlex Eco, Reprocessed ICE Catheter
Agilis NxT Steerable Introducer Dual Reach, Steerable Introducer
Advisor HD Grid X, Sensor Enabled, High Density Mapping Catheter
ViewFlex Xtra, ICE Catheter
Agilis NxT Introducer
CPS Excel MediGuide Guidewire
CPS Excel MediGuide Enabled Guidewire Models - DS2M031, DS2M032
Reflexion HD Mapping Catheter
Navitor Loading System
FlexNav Delivery System
FlexNav Loading System
Navitor Transcatheter Aortic Valve
Navitor Titan Transcatheter Aortic Valve
Navitor Loading System - LG+
Portico Transcatheter Aortic Valve
AMP-TFDM-01 Ampere Generator Software Upgrade
TSQ-V1.8-TFDM-01 TactiSys Quartz Equipment Software Upgrade
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Manufacture Device in the United States for Export Only