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

Manufacturer	Device Name	Date
K183320 St. Jude Medical (now Abbott Medical)	Ilumien Optis, Optis Integrated, Optis Mobile	2019-04-02
K183099 St. Jude Medical (now Abbott Medical)	QUANTIEN Measurement System	2019-02-28
K172396 St. Jude Medical	EnSite Velocity Cardiac Mapping System V5.2	2018-04-23
K172393 St. Jude Medical, Inc.	Advisor HD Grid Mapping Catheter, Sensor Enabled	2018-04-23
K180558 St. Jude Medical (now Part Of Abbott Medical)	PressureWire X	2018-03-28
K160335 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 D	2016-12-13
K160218 St. Jude Medical	AutoMark Module	2016-12-13
K160210 ST. JUDE MEDICAL	EnSite Precision Cardiac Mapping System V2.0	2016-12-13
K162643 ST. JUDE MEDICAL	MediGuide Technology System	2016-12-13
K161873 St. Jude Medical	Pacel Flow Directed Pacing Catheter	2016-11-22
K160187 ST. JUDE MEDICAL	Ensite Velocity Cardiac Mapping System V5.0, Ensite Automap Module V1.0	2016-10-21
K142254 St. Jude Medical	CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque Clip, CPS Excel MediGuide Guidewire Connector	2014-11-13
K141050 ST. JUDE MEDICAL	ENSITE VELOCITY SYSTEM	2014-06-06
K140327 ST. JUDE MEDICAL	ULTIMUM EV HEMOSTASIS INTRODUCER	2014-03-11
K132073 ST. JUDE MEDICAL	EP-WORKMATE, EP-NURSEMATE, EP-NURSEMATE WITH PHYSIO MODULE	2013-09-09
K130594 ST. JUDE MEDICAL	ENSITE VELOCITY SYSTEM	2013-05-03
K121006 ST. JUDE MEDICAL	ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER	2012-05-03
K120301 ST. JUDE MEDICAL, MEDIGUIDE NAVIGATION SYSTEMS	MEDIGUIDE TECHNOLOGY	2012-02-24
K112688 ST. JUDE MEDICAL	ENSITE VELOCITY SYSTEM V.3.0	2011-11-09
K111092 ST. JUDE MEDICAL	ENGAGE/ENGAGE TR INTRODUCERS	2011-06-09
K110085 ST. JUDE MEDICAL	VANTAGE VIEW SYSTEM	2011-01-26
K101968 ST. JUDE MEDICAL	SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A	2010-09-15
K093858 ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI	PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A	2010-04-02
K083328 ST. JUDE MEDICAL	ENSITE SYSTEM, MODEL EE3000, AND ENSITE NAVX SURFACE ELECTRODE, MODEL EN0010	2009-05-22
K090163 ST. JUDE MEDICAL	STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078	2009-04-01
K023447 ST. JUDE MEDICAL	MODIFICATION TO ULTIMUM EV HEMOSTASIS INTRODUCER (22F)	2002-10-31
K002976 ST. JUDE MEDICAL	RESPONSE ELECTROPHYSIOLOGY CATHETER, SUPREME ELECTROPHYSIOLOGY CATHETER, MODEL 401XXX AND 401XXX	2000-12-22
K001346 ST. JUDE MEDICAL, INC.	ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX	2000-05-24

Latest Premarket Applications

PMA	Manufacturer	Device Name	Date
P910023S421	St. Jude Medical	Ellipse ICD s	2019-11-14
P100045S040	St. Jude Medical	CardioMEMS HF System	2019-10-29
P130026S052	St. Jude Medical	TactiCath Quartz Contact Force Ablation Catheter and TactiCath Contact Force Ablation Catheter, Sensor Enabled	2019-10-25
P960016S080	St. Jude Medical	Livewire TC Ablation, Livewire TC Cables, Safire Ablation Catheter and Safire Cables	2019-10-25
P110016S065	St. Jude Medical, Inc. (Irvine Biomedical)	FlexAbility and FlexAbility SE Ablation Catheter and FlexAbility Cables, Sensor Enabled	2019-10-25
P960030S067	St. Jude Medical	ISOFLEX	2019-10-24
P140033S047	St. Jude Medical, Inc.	TENDRIL MRI	2019-10-24
P950022S128	St. Jude Medical, Inc.	Durata and Optisure HV Active Steroid Eluting Cardiac Leads	2019-10-24
P130026S053	St. Jude Medical	TactiCath Quartz Catheter Contact Force Ablation Catheter	2019-10-22
P910023S420	St. Jude Medical	Ellipse hybrid	2019-10-18
P030054S371	St. Jude Medical	Quadra Assura, Unify, Unify Assura and Unify Quadra CRT-D	2019-10-15
P910023S419	St. Jude Medical	Ellipse, Fortify, Fortify Assura and Quadra Assura MP ICD	2019-10-15
P130026S051	St. Jude Medical	TactiCath Contact Force Ablation Catheter, Sensor Enabled	2019-10-09
P110016S064	St. Jude Medical, Inc. (Irvine Biomedical)	FlexAbility Ablation Catheter and FlexAbility Ablation Catheter, Sensor Enabled	2019-10-09
P130026S050	St. Jude Medical	TactiCath Quartz Contact Force Ablation Catheter	2019-09-18
P030054S370	St. Jude Medical	Quadra Assura, Unify, Unify Assura, and Unify Quadra CRT-D s	2019-09-04
P910023S418	St. Jude Medical	Ellipse, Fortify, Fortify Assura, and Quadra Assura MP ICD s	2019-09-04
P140033S046	St. Jude Medical, Inc.	Tendril MRI Steroid Eluting Cardiac Leads	2019-08-30
P960016S079	St. Jude Medical	LIVEWIRE(R) CARDIAC ABLATION SYSTEM	2019-08-22
P110016S063	St. Jude Medical, Inc. (Irvine Biomedical)	THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR	2019-08-22
P030054S369	St. Jude Medical	Unify, Unify Quadra/Assura and Quadra Assura/MP	2019-08-19
P910023S417	St. Jude Medical	Fortify and Fortify Assura ICD s	2019-08-19
P130026S049	St. Jude Medical	TACTICATH QUARTZ SET	2019-07-24
P130026S047	St. Jude Medical	TactiCath Quartz Contact Force Ablation Catheter	2019-06-19
P130026S046	St. Jude Medical	TactiSys Quartz System	2019-06-13
P910023S416	St. Jude Medical	Torque Wrench/Torque Driver	2019-05-30
P140033S045	St. Jude Medical, Inc.	Tendril MRI Steroid Eluting Cardiac Leads	2019-05-29
P040021S041	St. Jude Medical, Inc.	Biocor, Biocor Supra, Epic, and Epic Supra Valves	2019-05-20
P100029S040	St. Jude Medical, Inc.	Trifecta Valve and Trifecta Valve with Glide Technology (Trifecta GT)	2019-05-20
P130026S045	St. Jude Medical	Tacticath Contact Force Ablation Catheter, Sensor Enabled (Tacticath SE)	2019-05-07

Latest De Novo Filings

De Novo	Manufacturer	Device Name	Date

GUDID Registrations

Device GUDID Device Name	Manufacturer	Date
05415067027283 Advisor™ VL	ST. JUDE MEDICAL, INC.	2019-10-04
05415067027276 Advisor™ VL	ST. JUDE MEDICAL, INC.	2019-10-04
05415067027269 Advisor™ VL	ST. JUDE MEDICAL, INC.	2019-10-04
05415067027252 Advisor™ VL	ST. JUDE MEDICAL, INC.	2019-10-04
05415067031471 Advisor™	ST. JUDE MEDICAL, INC.	2019-10-01
05415067030092 Advisor™	ST. JUDE MEDICAL, INC.	2019-10-01
05414734210188 EnSite™	ST. JUDE MEDICAL, INC.	2019-10-01
05415067031426 Proclaim™	ST. JUDE MEDICAL, INC.	2019-09-19
05415067031419 Proclaim™	ST. JUDE MEDICAL, INC.	2019-09-19
05415067005847 VantageView™	ST. JUDE MEDICAL, INC.	2019-07-22
05414734218436 VantageView™	ST. JUDE MEDICAL, INC.	2019-07-22
05414734218429 VantageView™	ST. JUDE MEDICAL, INC.	2019-07-22
05414734218412 VantageView™	ST. JUDE MEDICAL, INC.	2019-07-22
05415067026293 EnSite™ Verismo™	ST. JUDE MEDICAL, INC.	2019-07-22
05415067026279 EnSite Precision™	ST. JUDE MEDICAL, INC.	2019-07-22
05415067026248 FlexAbility™ Ablation Catheter, Sensor Enabled™	ST. JUDE MEDICAL, INC.	2019-07-22
05415067026231 Advisor™ FL Mapping Catheter, Sensor Enabled™	ST. JUDE MEDICAL, INC.	2019-07-22
05415067026224 EnSite™ Fusion™	ST. JUDE MEDICAL, INC.	2019-07-22
05415067026217 EnSite™ Derexi™	ST. JUDE MEDICAL, INC.	2019-07-22
05415067026200 EnSite™	ST. JUDE MEDICAL, INC.	2019-07-22
05415067026194 EnSite™	ST. JUDE MEDICAL, INC.	2019-07-22
05415067026187 EnSite™ Courier™	ST. JUDE MEDICAL, INC.	2019-07-22
05415067026170 EnSite™ Courier™	ST. JUDE MEDICAL, INC.	2019-07-22
05415067026163 EnSite™	ST. JUDE MEDICAL, INC.	2019-07-22
05415067004703 VantageView™	ST. JUDE MEDICAL, INC.	2019-07-22
05415067026132 EnSite™	ST. JUDE MEDICAL, INC.	2019-07-22
05415067004697 MediGuide™	ST. JUDE MEDICAL, INC.	2019-07-22
05415067004680 MediGuide™	ST. JUDE MEDICAL, INC.	2019-07-22
05415067026118 EnSite Precision™	ST. JUDE MEDICAL, INC.	2019-07-22
05415067026101 EnSite™ Velocity™	ST. JUDE MEDICAL, INC.	2019-07-22
05415067025975 Advisor™	ST. JUDE MEDICAL, INC.	2019-07-22
05415067025968 Advisor™	ST. JUDE MEDICAL, INC.	2019-07-22
05415067004604 MediGuide™	ST. JUDE MEDICAL, INC.	2019-07-22
15415067025934 EnSite Precision™	ST. JUDE MEDICAL, INC.	2019-07-22
05415067018519 MediGuide¿™	ST. JUDE MEDICAL, INC.	2019-07-22