St. Jude Medical

FDA Filings

This page includes the latest FDA filings for St. Jude Medical. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
St. Jude Medical (now Abbott Medical)
Ilumien Optis, Optis Integrated, Optis Mobile2019-04-02
St. Jude Medical (now Abbott Medical)
QUANTIEN Measurement System2019-02-28
St. Jude Medical
EnSite Velocity Cardiac Mapping System V5.22018-04-23
St. Jude Medical, Inc.
Advisor HD Grid Mapping Catheter, Sensor Enabled2018-04-23
St. Jude Medical (now Part Of Abbott Medical)
PressureWire X2018-03-28
St. Jude Medical
Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D2016-12-13
St. Jude Medical
AutoMark Module2016-12-13
ST. JUDE MEDICAL
EnSite Precision Cardiac Mapping System V2.02016-12-13
ST. JUDE MEDICAL
MediGuide Technology System2016-12-13
St. Jude Medical
Pacel Flow Directed Pacing Catheter2016-11-22
ST. JUDE MEDICAL
Ensite Velocity Cardiac Mapping System V5.0, Ensite Automap Module V1.02016-10-21
St. Jude Medical
CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque Clip, CPS Excel MediGuide Guidewire Connector2014-11-13
ST. JUDE MEDICAL
ENSITE VELOCITY SYSTEM2014-06-06
ST. JUDE MEDICAL
ULTIMUM EV HEMOSTASIS INTRODUCER2014-03-11
ST. JUDE MEDICAL
EP-WORKMATE, EP-NURSEMATE, EP-NURSEMATE WITH PHYSIO MODULE2013-09-09
ST. JUDE MEDICAL
ENSITE VELOCITY SYSTEM2013-05-03
ST. JUDE MEDICAL
ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER2012-05-03
ST. JUDE MEDICAL, MEDIGUIDE NAVIGATION SYSTEMS
MEDIGUIDE TECHNOLOGY2012-02-24
ST. JUDE MEDICAL
ENSITE VELOCITY SYSTEM V.3.02011-11-09
ST. JUDE MEDICAL
ENGAGE/ENGAGE TR INTRODUCERS2011-06-09
ST. JUDE MEDICAL
VANTAGE VIEW SYSTEM2011-01-26
ST. JUDE MEDICAL
SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A2010-09-15
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A2010-04-02
ST. JUDE MEDICAL
ENSITE SYSTEM, MODEL EE3000, AND ENSITE NAVX SURFACE ELECTRODE, MODEL EN00102009-05-22
ST. JUDE MEDICAL
STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 40782009-04-01
ST. JUDE MEDICAL
MODIFICATION TO ULTIMUM EV HEMOSTASIS INTRODUCER (22F)2002-10-31
ST. JUDE MEDICAL
RESPONSE ELECTROPHYSIOLOGY CATHETER, SUPREME ELECTROPHYSIOLOGY CATHETER, MODEL 401XXX AND 401XXX2000-12-22
ST. JUDE MEDICAL, INC.
ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX2000-05-24

Latest Premarket Applications

PMAManufacturerDevice NameDate
St. Jude Medical
Ellipse ICD s2019-11-14
St. Jude Medical
CardioMEMS HF System2019-10-29
St. Jude Medical
TactiCath Quartz Contact Force Ablation Catheter and TactiCath Contact Force Ablation Catheter, Sensor Enabled2019-10-25
St. Jude Medical
Livewire TC Ablation, Livewire TC Cables, Safire Ablation Catheter and Safire Cables2019-10-25
St. Jude Medical, Inc. (Irvine Biomedical)
FlexAbility and FlexAbility SE Ablation Catheter and FlexAbility Cables, Sensor Enabled2019-10-25
St. Jude Medical
ISOFLEX2019-10-24
St. Jude Medical, Inc.
TENDRIL MRI2019-10-24
St. Jude Medical, Inc.
Durata and Optisure HV Active Steroid Eluting Cardiac Leads2019-10-24
St. Jude Medical
TactiCath Quartz Catheter Contact Force Ablation Catheter2019-10-22
St. Jude Medical
Ellipse hybrid2019-10-18
St. Jude Medical
Quadra Assura, Unify, Unify Assura and Unify Quadra CRT-D2019-10-15
St. Jude Medical
Ellipse, Fortify, Fortify Assura and Quadra Assura MP ICD2019-10-15
St. Jude Medical
TactiCath Contact Force Ablation Catheter, Sensor Enabled2019-10-09
St. Jude Medical, Inc. (Irvine Biomedical)
FlexAbility Ablation Catheter and FlexAbility Ablation Catheter, Sensor Enabled2019-10-09
St. Jude Medical
TactiCath Quartz Contact Force Ablation Catheter2019-09-18
St. Jude Medical
Quadra Assura, Unify, Unify Assura, and Unify Quadra CRT-D s2019-09-04
St. Jude Medical
Ellipse, Fortify, Fortify Assura, and Quadra Assura MP ICD s2019-09-04
St. Jude Medical, Inc.
Tendril MRI Steroid Eluting Cardiac Leads2019-08-30
St. Jude Medical
LIVEWIRE(R) CARDIAC ABLATION SYSTEM2019-08-22
St. Jude Medical, Inc. (Irvine Biomedical)
THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR2019-08-22
St. Jude Medical
Unify, Unify Quadra/Assura and Quadra Assura/MP2019-08-19
St. Jude Medical
Fortify and Fortify Assura ICD s2019-08-19
St. Jude Medical
TACTICATH QUARTZ SET2019-07-24
St. Jude Medical
TactiCath Quartz Contact Force Ablation Catheter2019-06-19
St. Jude Medical
TactiSys Quartz System2019-06-13
St. Jude Medical
Torque Wrench/Torque Driver2019-05-30
St. Jude Medical, Inc.
Tendril MRI Steroid Eluting Cardiac Leads2019-05-29
St. Jude Medical, Inc.
Biocor, Biocor Supra, Epic, and Epic Supra Valves2019-05-20
St. Jude Medical, Inc.
Trifecta Valve and Trifecta Valve with Glide Technology (Trifecta GT)2019-05-20
St. Jude Medical
Tacticath Contact Force Ablation Catheter, Sensor Enabled (Tacticath SE)2019-05-07

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
Advisor™ VL
ST. JUDE MEDICAL, INC.2019-10-04
Advisor™ VL
ST. JUDE MEDICAL, INC.2019-10-04
Advisor™ VL
ST. JUDE MEDICAL, INC.2019-10-04
Advisor™ VL
ST. JUDE MEDICAL, INC.2019-10-04
Advisor™
ST. JUDE MEDICAL, INC.2019-10-01
Advisor™
ST. JUDE MEDICAL, INC.2019-10-01
EnSite™
ST. JUDE MEDICAL, INC.2019-10-01
Proclaim™
ST. JUDE MEDICAL, INC.2019-09-19
Proclaim™
ST. JUDE MEDICAL, INC.2019-09-19
VantageView™
ST. JUDE MEDICAL, INC.2019-07-22
VantageView™
ST. JUDE MEDICAL, INC.2019-07-22
VantageView™
ST. JUDE MEDICAL, INC.2019-07-22
VantageView™
ST. JUDE MEDICAL, INC.2019-07-22
EnSite™ Verismo™
ST. JUDE MEDICAL, INC.2019-07-22
EnSite Precision™
ST. JUDE MEDICAL, INC.2019-07-22
FlexAbility™ Ablation Catheter, Sensor Enabled™
ST. JUDE MEDICAL, INC.2019-07-22
Advisor™ FL Mapping Catheter, Sensor Enabled™
ST. JUDE MEDICAL, INC.2019-07-22
EnSite™ Fusion™
ST. JUDE MEDICAL, INC.2019-07-22
EnSite™ Derexi™
ST. JUDE MEDICAL, INC.2019-07-22
EnSite™
ST. JUDE MEDICAL, INC.2019-07-22
EnSite™
ST. JUDE MEDICAL, INC.2019-07-22
EnSite™ Courier™
ST. JUDE MEDICAL, INC.2019-07-22
EnSite™ Courier™
ST. JUDE MEDICAL, INC.2019-07-22
EnSite™
ST. JUDE MEDICAL, INC.2019-07-22
VantageView™
ST. JUDE MEDICAL, INC.2019-07-22
EnSite™
ST. JUDE MEDICAL, INC.2019-07-22
MediGuide™
ST. JUDE MEDICAL, INC.2019-07-22
MediGuide™
ST. JUDE MEDICAL, INC.2019-07-22
EnSite Precision™
ST. JUDE MEDICAL, INC.2019-07-22
EnSite™ Velocity™
ST. JUDE MEDICAL, INC.2019-07-22
Advisor™
ST. JUDE MEDICAL, INC.2019-07-22
Advisor™
ST. JUDE MEDICAL, INC.2019-07-22
MediGuide™
ST. JUDE MEDICAL, INC.2019-07-22
EnSite Precision™
ST. JUDE MEDICAL, INC.2019-07-22
MediGuide¿™
ST. JUDE MEDICAL, INC.2019-07-22

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