St Jude Medical EnSite Precision Cardiac Mapping System

Ülke: Singapur

Dil: İngilizce

Kaynak: HSA (Health Sciences Authority)

Mevcut itibaren:

ABBOTT MEDICAL (SINGAPORE), PTE. LTD.

Sınıf:

Class D medical device

Tarafından üretildi:

St. Jude Medical

Terapötik alanı:

Cardiovascular

Terapötik endikasyonlar:

The EnSite Precision™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated. The EnSite Precision™ System interfaces to either the MediGuide™ Guided Medical Positioning System or the EnSite Precision™ Module to combine and display magnetic processed patient positioning and orientation mapping information. When used with the EnSite™ Array™ Catheter, the EnSite Precision™ Cardiac Mapping System is intended for use in electrophysiology studies to aid the electrophysiologist in diagnosing cardiac arrhythmia. When used with an EnSite Precision™ Surface Electrode Kit, the EnSite Precision™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.

Ürün özeti:

Device System Info:[Sterile Medical Device], EO Sterilization; Models: Ensite Amplifier and Display Workstation - EE3000, Ensite Display Workstation - EE3000, EnSite Verismo Software Installation - H00001, Ensite Fusion Software Upgrade Kit - H702506, EnSite Velocity Software Upgrade Kit - H702495, Ensite Precision Software Installation - H702496, Ensite AutoMap Module - H702498, EnSite Noise Reduction Transformer - H702483, AutoMark Software Installation - H702499, EnSite Velocity System Workstation Accessory Kit - 100045484, EnSite Precision Module, Sensor Enabled - H702473, EnSite Precision Module, Sensor Enabled Link - H702475, Fiber Optic Cable - 100111366, Ensite Precision Power Supply Kit - H702505, Ensite Precision Field Frame - H702469, Clamp, Bed Rail, EUR - 100007639, Ensite Contact Force Software Upgrade Kit - H702500, Advisor FL Mapping Catheter, Sensor Enabled Software Installation - H702507, Advisor FL, Sensor Enabled Circular Mapping Catheter - D-AVSE-D10-F20, Advisor FL, Sensor Enabled Circular Mapping Catheter - D-AVSE-DF10-F20, Advisor FL, Sensor Enabled Circular Mapping Catheter - D-AVSE-D10-F15, Advisor FL, Sensor Enabled Circular Mapping Catheter - D-AVSE-DF10-F15, Sensor Enabled Cable Diagnostic Catheter Cable - D-AVSE-CBL12, EnSite Velocity Amplifier - 100014514, EnSite Precision Software Installation - H702469-SW, EnSite Precision System Software Upgrade - H702602, EnSite Precision Software Installation - H702701, EnSite Precision Software Upgrade - H704001

Yetkilendirme tarihi:

2018-12-18