FDA Registration
Active
🇨🇷 Costa Rica
Abbott Medical Costa Rica Ltda.
Reg #: 3008452825
·
FEI: 3008452825
·
Expires 2026
Products
11
Proprietary Names
388
Establishment Types
2
Classifications
11
Registration Details
- Registration Name
- Abbott Medical Costa Rica Ltda.
- Registration Number
- 3008452825
- FEI Number
- 3008452825
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Edificio #44 Calle 0, Ave. 2, Zona Franca Coyol
- City
- El Coyol Alajuela
- Country
- CR
Regulatory Submissions
- 510(k) Number
- K061363
- PMA Number
- P250022
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 | 2009-08-20 |
| Catheter, Ultrasound, Intravascular | OBJ | Class 2 | Cardiovascular | No | 2025-09-04 |
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2020-06-30 |
| Catheter, Electrode Recording, Or Probe, Electrode Recording | DRF | Class 2 | Cardiovascular | No | 2016-12-13 |
| Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation | QZI | Class 3 | Unknown | No | 2025-12-22 |
| Catheter, Intracardiac Mapping, High-Density Array | MTD | Class 2 | Cardiovascular | No | 2018-04-24 |
| Trocar | DRC | Class 2 | Cardiovascular | No | 2021-01-11 |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | OAE | Class 3 | Unknown | No | 2023-05-19 |
| Reprocessed Intravascular Ultrasound Catheter | OWQ | Class 2 | Cardiovascular | No | 2025-07-01 |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter | OAD | Class 3 | Unknown | No | 2012-02-06 |
| Cardiac Ablation Percutaneous Catheter | LPB | Class 3 | Unknown | No | 2012-02-06 |
Proprietary Names
Agilis NxT Steerable Introducer
ViewFlex Xtra ICE Catheter
ViewFlex X ICE 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
Advisor FL Circular Mapping Catheter, Sensor Enabled
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
Agilis NxT Introducer
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
EnSite X EP System IC Output Cable, ENSITE-WM56-60-01
EnSite X EP System Amplifier, ENSITE-AMP-02
EnSite X EP System Display Workstation, ENSITE-DWS-1.1
EnSite X EP System Radio-opaque ECG Lead Set, ENSITE-ECGRO-01
EnSite X EP System Bedrail Mount, ENSITE-RAILMNT-01
EnSite X EP System IC Output Cable, ENSITE-WM64-144-01
EnSite X EP System Amplifier Cart, ENSITE-AMPCART3-01
EnSite X EP System Wave Speed Map, ENSITE-WS-01
EnSite X EP System Field Frame, ENSITE-R-FF-01
EnSite X EP System Single Monitor Mount, ENSITE-SMMK-01
EnSite X EP System Display Workstation, ENSITE-R-DWS-1.1
EnSite X EP System Amplifier Power Module, ENSITE-AMP-EPM-01
EnSite X EP System Recording System IC Output Cable, ENSITE-CR-56-01
EnSite X EP System Live Export Software License, ENSITE-LE-01
EnSite X EP System Amplifier, ENSITE-AMP-01
EnSite X EP System EnSite Omnipolar Technology Demo, ENSITE-D-OT-01
EnSite X EP System Display Workstation Cart, ENSITE-DWSCART-01
EnSite X EP System EnSite Omnipolar Technology Data Export, ENSITE-OTEXPORT-01
EnSite X EP System Field Frame, ENSITE-FF-01
EnSite X EP System Dual Monitor Mount, ENSITE-DMMK-01
EnSite X EP System Catheter Input Module, ENSITE-CIM-80-01
EnSite X EP System EnSite Omnipolar Technology, ENSITE-OT-01
EnSite X EP System Surface Electrode Kit, ENSITE-SEK-5-01
EnSite X EP System Remote Monitor Stand, ENSITE-RMS-01
EnSite X EP System EnSite LiveView Dynamic Display, ENSITE-LV-01
EnSite X EP System Recording System IC Output Cable, ENSITE-CR-64-01
EnSite X EP System Display Workstation, ENSITE-R-DWS-01
EnSite X EP System Contact Force Software License, ENSITE-CF-01
EnSite X EP System Connect Cable, ENSITE-ACBL-60-01
EnSite X EP System Monitor Pole, ENSITE-MONPOLE-01
EnSite X EP System Field Frame Cable, ENSITE-FF-4.5C-01
EnSite X EP System IC Output Cable, ENSITE-WM64-60-01
EnSite X EP System ECG Cable, ENSITE-CECG-60-01
EnSite X EP System Catheter Input Module, ENSITE-CIM-20-01
EnSite X EP System Radio-lucent ECG Lead Set, ENSITE-ECGRL-01
EnSite X EP System EnSite LiveView Dynamic Display Demo, ENSITE-D-LV-01
EnSite X EP System Patient Reference Sensor, ENSITE-PRSFRNT-01
EnSite X EP System Patient Reference Sensor, ENSITE-PRSBACK-01
EnSite X EP System Amplifier, ENSITE-R-AMP-02
EnSite X EP System IC Output Cable, ENSITE-WM56-144-01
EnSite Adjustable Field Frame Bracket, ENSITE-FF-ABRKT-01
EnSite X EP System Amplifier, ENSITE-R-AMP-01
EnSite Fixed Field Frame Bracket, ENSITE-FF-BRCKT-01
EnSite X EP System Software Upgrade, ENSITE-SW-1.1
EnSite X EP System Triple Monitor Mount, ENSITE-TMMK-01
EnSite X EP System Connect Cable, ENSITE-ACBL-160-01
EnSite X EP System Contact Force Software License, ENSITE-D-CF-01
EnSite X EP System Display Workstation, ENSITE-DWS-01
EnSite X EP System SurfaceLink Module, ENSITE-SRFLNK-01
EnSite X EP System Amplifier Cart, ENSITE-AMPCART1-01
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 ECG Cable, ENSITE-CECG-144-01
EnSite X EP System ECG Output Module, ENSITE-ECGOUT-01
Advisor VL Circular Mapping Catheter, Sensor Enabled
Epicardial Catheter System
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
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
Agilis NxT Steerable Introducer Dual-Reach, Steerable Introducer
Agilis NxT Steerable Introducer
Advisor HD Grid Sensor Enabled, High Density Mapping Catheter
ViewFlex Eco, Reprocessed ICE Catheter
Agilis NxT Steerable Introducer Dual Reach, Steerable Introducer
Agilis NxT, Steerable Introducer
Advisor HD Grid X, Sensor Enabled, High Density Mapping Catheter
ViewFlex Xtra, ICE Catheter
Response Electrophysiology Catheter
MediGuide Enabled Livewire Steerable Electrophysiology Catheter
Livewire Steerable Electrophysiology Catheter
Response Electrophysiology Catheter with Lumen
Supreme Electrophysiology Catheter
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
ViewFlex Xtra ICE Catheter D087031
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-CECG-60-01 EnSite X EP System ECG Cable
ENSITE-OTAC-02 EnSite X EP System OTA Certificate Software License
ENSITE-ECGOUT-01 EnSite X EP System ECG Output Module
ENSITE-SW-1.1 EnSite X EP System Software Upgrade
ENSITE-IMP-01 EnSite X EP System, Averaged Impedance Drop, Software License
ENSITE-D-LV-01 EnSite X EP System EnSite LiveView Dynamic Display Demo Software License
ENSITE-SW-1.1.1 EnSite X EP System Software Upgrade
ENSITE-SW-03 EnSite X EP System Software Upgrade
ENSITE-MONPOLE-01 EnSite X EP System Monitor Pole
ENSITE-SW-3.1 EnSite X EP System, Software Upgrade
ENSITE-FF-ABRKT-01 EnSite Adjustable Field Frame Bracket
ENSITE-ACBL-60-01 EnSite X EP System Connect Cable
ENSITE-AMPCART3-01 EnSite X EP System Amplifier Cart
ENSITE-FF-4.5C-01 EnSite X EP System Field Frame Cable
ENSITE-DWSCART-01 EnSite X EP System Display Workstation Cart
ENSITE-SMMK-01 EnSite X EP System Single Monitor Mount
ENSITE-TFM-03 EnSite X EP System, TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade
ENSITE-R-AMP-01 EnSite X EP System Amplifier
ENSITE-TFM-3.1 EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software Upgrade
ENSITE-AMD-01 EnSite X EP System, AutoMark Distance, Software License
ENSITE-WM64-60-01 EnSite X EP System IC Output Cable
ENSITE-DWS-3.1 EnSite X EP System, Display Workstation
ENSITE-CF-01 EnSite X EP System Contact Force Software License
ENSITE-FF-01 EnSite X EP System Field Frame
ENSITE-SYSTEM-3.1 EnSite X EP System
ENSITE-AAF-01 EnSite X Amplifier Air Filter
ENSITE-SW-1.1.2 EnSite X EP System, Software Upgrade
ENSITE-R-FF-01 EnSite X EP System Field Frame
ENSITE-FWV-02 EnSite X EP System, EnSite PFA Catheter Visualization Software License
ENSITE-D-LS-01 EnSite X EP System, LiveSync Demo, Software License
ENSITE-RMS-01 EnSite X EP System Remote Monitor Stand
ENSITE-OT-01 EnSite X EP System EnSite Omnipolar Technology Software License
ENSITE-SYSTEM-201 EnSite X EP System
ENSITE-ACBL-160-01 EnSite X EP System Connect Cable
ENSITE-DWS-1.1 EnSite X EP System Display Workstation
ENSITE-OTAC-01 EnSite X EP System OTA Certificate Software License
ENSITE-GENECG-NAM EnSite X EP System PFA ECG Signal Splitter
ENSITE-WM64-144-01 EnSite X EP System IC Output Cable
ENSITE-HDGX-01 EnSite X EP System Advisor HD Grid X Mapping Catheter, Sensor Enabled, Software License
ENSITE-D-AMD-01 EnSite X EP System, AutoMark Distance Demo, Software License
ENSITE-D-ADASLV-01 ADAS 3D LV License Temporary Software License
ENSITE-SEK-5-01 EnSite X EP System Surface Electrode Kit
ENSITE-SW-2 EnSite X EP System Software Upgrade
ENSITE-CECG-144-01 EnSite X EP System ECG Cable
ENSITE-D-IMP-01 EnSite X EP System, Averaged Impedance Drop Demo, Software License
ENSITE-DWS-2.1 EnSite X EP System Display Workstation
ENSITE-R-DWS-3.1 EnSite X EP System, Display Workstation
ENSITE-AMP-EPM-01 EnSite X EP System Amplifier Power Module
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-SW-3.2 EnSite X EP System Software Upgrade v3.2
ENSITE-WM56-144-01 EnSite X EP System IC Output Cable
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-AMP-02 EnSite X EP System Amplifier
ENSITE-R-DWS-1.1 EnSite X EP System Display WorkStation
ENSITE-D-FLEX-01 EnSite X EP System, VoXel Flex Demo, Software License
ENSITE-TMMK-01 EnSite X EP System Triple Monitor Mount Kit
ENSITE-D-OT-01 EnSite X EP System EnSite Omnipolar Technology Demo Software License
ENSITE-D-FWV-01 EnSite X EP System, EnSite PFA Catheter Visualization Temporary, Software License
ENSITE-FF-3MC-01 EnSite X EP System Field Frame Cable
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-ECGRO-01 EnSite X EP System Radio-opaque ECG Lead set
ENSITE-FF-BRCKT-01 EnSite Fixed Field Frame Bracket
ENSITE-CR-56-01 EnSite X EP System Recording System IC Output Cable
ENSITE-TFM-3.2 EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software Upgrade
ENSITE-FLEX-01 EnSite X EP System, VoXel Flex, Software License
ENSITE-CL-01 EnSite X EP System EnSite Cloud Software License
ENSITE-R-DWS-01 EnSite X EP System Display Workstation
ENSITE-TFM-02 EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade
ENSITE-R-DWS-2.1 EnSite X EP System Display Workstation
ENSITE-D-WS-01 EnSite X EP System Wave Speed Map Demo Software License
ENSITE-CR-64-01 EnSite X EP System Recording System IC Output Cable
ENSITE-ECGRL-01 EnSite X EP System, Radio-lucent ECG Lead Set
ENSITE-LE-01 EnSite X EP System Live Export Software License
ENSITE-DMMK-01 EnSite X EP System Dual Monitor Mount
ENSITE-DWS-01 EnSite X EP System Display Workstation
ENSITE-AMP-01 EnSite X EP System Amplifier
ENSITE-LV-01 EnSite X Ep System EnSite LiveView Dynamic Display Software License
ENSITE-PRSFRNT-01 EnSite X EP System Patient Reference Sensor
ENSITE-TF-02 EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled Software License
ENSITE-R-AMP-02 EnSite X EP System Amplifier
ENSITE-SW-2.1 EnSite X EP System Software Upgrade
ENSITE-FWV-01 EnSite X EP System EnSite PFA Catheter Visualization, Software License
ENSITE-SRFLNK-01 EnSite X EP System SurfaceLink Module
ENSITE-AM-2 EnSite X EP System Advanced Mapping Software License
ENSITE-SW-1.2 EnSite X EP System Software Upgrade
ENSITE-RAILMNT-01 EnSite X EP System Bedrail Mount
ENSITE-PRSBACK-01 EnSite X EP System Patient Reference Sensor
ENSITE-LS-01 EnSite X EP System, LiveSync, Software License
ENSITE-AMPCART1-01 EnSite X EP System Amplifier Cart
ENSITE-SYSTEM-111 EnSite X EP System
ENSITE-WM56-60-01 EnSite X EP System IC Output Cable
ENSITE-D-AM-2 EnSite X EP System Advanced Mapping Demo Software License
ENSITE-D-CF-01 EnSite X EP System Contact Force Software License
ENSITE-CIM-80-01 EnSite X EP System Catheter Input Module
ENSITE-CIM-20-01 EnSite X EP System Catheter Input Module
ENSITE-OTEXPORT-01 EnSite X EP System EnSite Omnipolar Technology Data Export Software License
ENSITE-WS-01 EnSite X EP System Wave Speed Map 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
EnSite Precision Cardiac Mapping System, v2.1
TactiSys Quartz Equipment
TactiCath Contact Force Ablation Catheter, Sensor Enabled
Ampere Generator
Ampere Generator Fiber Cord Assembly Remote
EnSite X EP System Level Order Number ENSITE-SYSTEM-111
ENSITE-ECGRL-01 EnSite X EP System Radio-lucent ECG Lead set
EnSite X EP System Level Order Number ENSITE-SYSTEM-201
EnSite X EP System Software Upgrade, ENSITE-SW-1.1.2
EnSite X EP System Software Upgrade, ENSITE-SW-1.1.1
Advisor HD Grid X, Sensor Enabled High Density Mapping Catheter
Advisor HD Grid X Mapping Catheter, Sensor Enabled
FlexAbility Ablation Catheter
Sensor Enabled Ablation Connection Cable
Therapy Cool Flex Ablation Catheter
FlexAbility Ablation Catheter, Sensor Enabled
Therapy Cool Path Duo Ablation Catheter
Safire BLU Duo Ablation Catheter
IBI 1500T9-CP V1.6 Cardiac Ablation Generator
Ampere Generator Accessories
Ampere Footswitch
EnSite X EP System Software Upgrade
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
Response Electrophysiology Catheter
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility