St. Jude Medical, Inc

FDA Filings

This page includes the latest FDA filings for St. Jude Medical, Inc. 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
MyMerlin(TM) Mobile Application Model APP10012017-11-02
St. Jude Medical, Inc.
Confirm Rx Insertable Cardiac Monitor (ICM) System2017-09-29
St. Jude Medical (now Part Of The Abbott Medical)
QUANTIEN Measurement System2017-08-18
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
EnSite Velocity Surface Electrode Kit2016-10-07
ST. JUDE MEDICAL INC.
PressureWire X Guidewire2016-08-15
ST. JUDE MEDICAL
Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover2016-06-09
ST. JUDE MEDICAL
Pacel Bipolar Pacing Catheters2015-10-22
ST. JUDE MEDICAL
WorkMate Claris System, WorkMate Claris System Display Plus2015-10-22
St. Jude Medical
St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Electrophysiology Catheter, Response Electrophysiology Catheter With Lumen, Response Electrophysiology Catheter And SJM Epicardial Catheter System, Supreme Elec2015-07-15
St. Jude Medical
St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter, Livewire Electrophysiology Catheter2015-04-01
St. Jude Medical
CPS Aim MediGuide Enabled Inner Catheter, CPS Aim Mediguide Enabled Inner Catheter2014-12-18
St. Jude Medical
CPS Direct MediGuide Enabled Outer Catheter2014-12-18
ST. JUDE MEDICAL, INC.
NANOSTIM INTRODUCER KIT2014-12-17
ST. JUDE MEDICAL SYSTEMS AB
PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS AGILE TIP, CERTUS AGILE TIP 3002014-11-13
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, INC.
SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM)2014-05-28
ST. JUDE MEDICAL
SWIFT-LOCK ANCHOR2014-05-02
ST. JUDE MEDICAL
ULTIMUM EV HEMOSTASIS INTRODUCER2014-03-11

Latest Premarket Applications

PMAManufacturerDevice NameDate
St. Jude Medical
TactiCath Contact Force Ablation Catheter, Sensor Enabled2020-03-27
St. Jude Medical
Isoflex2020-03-26
St. Jude Medical
Quickflex, Quartet2020-03-26
St. Jude Medical, Inc.
Durata, Optisure2020-03-26
St. Jude Medical, Inc.
Tendril MRI2020-03-26
St. Jude Medical
Ellipse DR and Ellipse VR2020-03-13
St. Jude Medical, Inc. (Irvine Biomedical)
Therapy Cool Path Duo Ablation Catheter2020-03-04
St. Jude Medical
Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP, QuickFlex µ, Quartet, Quartet CRT Leads, and Quartet2020-02-28
St. Jude Medical
Fortify, Fortify Assura, and Ellipse2020-02-28
St. Jude Medical, Inc.
Allure, Allure Quadra, and Quadra Allure MP2020-02-28
St. Jude Medical, Inc.
Assurity MRI, Endurity MRI, MRI Activator, and Tendril MRI2020-02-28
St. Jude Medical, Inc.
Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL, Sustain XL DC, Sust2020-02-28
St. Jude Medical, Inc.
Microny2020-02-28
St. Jude Medical, Inc.
Durata and Optisure2020-02-24
St. Jude Medical
CardioMEMS HF System2020-02-05
St. Jude Medical
TactiCath Contact Force Ablation Catheter, Sensor Enabled2020-01-14
St. Jude Medical
Promote+, Unify, Unify Quandra, Unify Assura, Quadra Assura, Quadra Assura MP2020-01-06
St. Jude Medical
Current+, Fortify, Fortify Assura, Ellipse2020-01-06
St. Jude Medical, Inc.
Endurity, Assurity, and Accent2020-01-06
St. Jude Medical, Inc.
Allure, Allure Quadra, Quadra Allure, Anthem, and Quadra Allure MP2020-01-06
St. Jude Medical, Inc.
Assurity MRI, Endurity MRI2020-01-06
St. Jude Medical, Inc.
Endurity MRI, and Assurity MRI2020-01-06
St. Jude Medical, Inc.
Endurity, Endurity Core, and Assurity pacemakers2020-01-06
St. Jude Medical
Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs2019-12-23
St. Jude Medical
Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+2019-12-23
St. Jude Medical, Inc.
Microny family of Pacemakers2019-12-23
St. Jude Medical, Inc.
Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps2019-12-23
St. Jude Medical
Quadripolar Pacing2019-12-20
St. Jude Medical
TactiCath Quartz Contact Force Ablation Catheter (TactiCath Quartz)2019-12-16
St. Jude Medical, Inc.
Assurity MRI and Endurity MRI Pacemakers2019-12-06

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
OPTISURE™
ST. JUDE MEDICAL, INC.2020-03-27
OPTISURE™
ST. JUDE MEDICAL, INC.2020-03-27
OPTISURE™
ST. JUDE MEDICAL, INC.2020-03-27
OPTISURE™
ST. JUDE MEDICAL, INC.2020-03-27
OPTISURE™
ST. JUDE MEDICAL, INC.2020-03-27
OPTISURE™
ST. JUDE MEDICAL, INC.2020-03-27
OPTISURE™
ST. JUDE MEDICAL, INC.2020-03-27
OPTISURE™
ST. JUDE MEDICAL, INC.2020-03-27
OPTISURE™
ST. JUDE MEDICAL, INC.2020-03-27
OPTISURE™
ST. JUDE MEDICAL, INC.2020-03-27
OPTISURE™
ST. JUDE MEDICAL, INC.2020-03-27
OPTISURE™
ST. JUDE MEDICAL, INC.2020-03-27
OPTISURE™
ST. JUDE MEDICAL, INC.2020-03-27
OPTISURE™
ST. JUDE MEDICAL, INC.2020-03-27
OPTISURE™
ST. JUDE MEDICAL, INC.2020-03-27
OPTISURE™
ST. JUDE MEDICAL, INC.2020-03-27
OPTISURE™
ST. JUDE MEDICAL, INC.2020-03-27
OPTISURE™
ST. JUDE MEDICAL, INC.2020-03-27
OPTISURE™
ST. JUDE MEDICAL, INC.2020-03-27
OPTISURE™
ST. JUDE MEDICAL, INC.2020-03-27
OPTISURE™
ST. JUDE MEDICAL, INC.2020-03-27
Durata™
ST. JUDE MEDICAL, INC.2020-03-26
OPTISURE™
ST. JUDE MEDICAL, INC.2020-03-26
OPTISURE™
ST. JUDE MEDICAL, INC.2020-03-26
OPTISURE™
ST. JUDE MEDICAL, INC.2020-03-26
SJM™
ST. JUDE MEDICAL, INC.2020-03-05
SJM™
ST. JUDE MEDICAL, INC.2020-03-05
SJM™
ST. JUDE MEDICAL, INC.2020-03-05
Eon Mini™
ST. JUDE MEDICAL, INC.2020-02-06
Eon Mini™
ST. JUDE MEDICAL, INC.2020-02-06
Axium™
ST. JUDE MEDICAL, INC.2020-02-06
Axium™
ST. JUDE MEDICAL, INC.2020-02-06
Prodigy™
ST. JUDE MEDICAL, INC.2020-02-06
Eon™
ST. JUDE MEDICAL, INC.2020-02-06
Eon™
ST. JUDE MEDICAL, INC.2020-02-06

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