Medtronic

FDA Filings

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

Latest Premarket Notifications

ManufacturerDevice NameDate
Medtronic Sofamor Danek USA, INC.
Navigated Anterolateral Disc Prep Instruments2019-11-22
Medtronic Navigation, Inc.
Stealth Autoguide System, Midas Rex Legend Depth Stop System2019-11-01
Medtronic Sofamor Danek USA, INC.
Medtronic Transportation / Sterilization Cassettes2019-10-15
Medtronic Sofamor Danek, USA Inc.
CD Horizon™ Astute™ Spinal System2019-10-03
Medtronic, Inc.
Cardioblate CryoFlex Surgical Ablation System2019-10-01
Medtronic, Inc.
Affinity NT Oxygenator With Balance Biosurface, Affinity NT Oxygenator With Balance Biosurface And Uncoated Cardiotomy/Venous Reservoir2019-09-27
Medtronic, Inc
Patient Assistant Model PA970002019-09-24
Medtronic Inc
Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump With Balance Biosurface, Affinity CP Centrifugal Blood Pump With Cortive BioActive Surface, Medtronic External Drive Motor2019-08-27
Medtronic Sofamor Danek, USA Inc
Navigated T2 STRATOSPHERE Inserters And Navigated Templates2019-08-26
Medtronic
Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead2019-08-08
Medtronic Navigation Inc
StealthStation Synergy Cranial S7 Software V.2.2.8, StealthStation Cranial Software V3.1.12019-07-31
Medtronic
Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter, Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter2019-07-30
Medtronic
Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter2019-07-30
Medtronic Advanced Energy
Medtronic Total Hip Arthroplasty System2019-07-26
Medtronic Sofamor Danek USA, Inc
ARTiC-L 3D Ti Spinal System With TiONIC Technology, ARTiC-XL 3D Ti Spinal System With TiONIC Technology2019-07-03
Medtronic
Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device2019-05-30
Medtronic Powered Surgical Solutions
Stealth-Midas MR8 System2019-05-22
Medtronic Powered Surgical Solutions
MR8 Drill System, Midas Rex MR8 ClearView Tools2019-05-12
Medtronic Sofamor Danek USA, INC.
Capstone Control™ Spinal System2019-05-06
Medtronic, Inc.
Medtronic Model 5392 External Pulse Generator (EPG)2019-04-30
Medtronic, Inc. (formerly D.b.a. Ev3 Inc, Covidien Llc.)
EverCrossTM 0.035 OTW PTA Dilatation Catheter2019-04-23
Medtronic Inc
Affinity NT Oxygenator, Affinity NT Oxygenator With Trillium Biosurface, Affinity NT Oxygenator With Cortiva BioActive Surface, Affinity Fusion Oxygenator With Cortiva BioActive Surface, Affinity Fusion Oxygenator With Balance Biosurface2019-04-12
Medtronic Sofamor Danek USA, INC.
PYRAMESH™ Implant System2019-04-04
Medtronic, Inc.
Bio-Medicus Insertion Kit2019-04-03
Medtronic Inc.
Telescope Guide Extension Catheter2019-03-22
Medtronic Inc
Affinity Pixie™ Oxygenator With Balance™ Biosurface (Model BBP211), Affinity Pixie™ Oxygenator And Cardiotomy/Venous Reservoir With Balance™ Biosurface (Model BBP241), Affinity Pixie™ Oxygenator With Cortiva™ BioActive Surface (Model CBP211), Affinit2019-03-18
Medtronic Inc.
SelectSite C304-HIS Deflectable Catheter System2019-03-15
Medtronic Navigation Inc.
Visualase Thermal Therapy System2019-03-06
Medtronic
VS3-IR2019-03-04
Medtronic Sofamor Danek USA, Inc.
Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™ Anterior Cervical Plate, Venture™ Anterior Cervical Plate, Zephir™ Anterior Cervical Plate System And Zevo™ Anterior Cervical Plate System2019-02-06

Latest Premarket Applications

PMAManufacturerDevice NameDate
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
CapSure Sense Lead, CapSure SP Novus Lead and Vitatron Crystalline Lead2019-12-03
MEDTRONIC Inc.
INFUSE BONE GRAFT2019-11-29
Medtronic Sofamor Danek USA, Inc.
Infuse Bone Graft2019-11-29
Medtronic Sofamor Danek USA, Inc.
Infuse Bone Graft/Medtronic Interbody Fusion2019-11-29
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
CapSure Sense Lead2019-11-27
Medtronic, Inc
CapSureFix MRI Lead2019-11-27
Medtronic, Inc.
CapSureFix Novus Lead2019-11-27
MEDTRONIC Inc.
Micra Transcatheter Pacing System2019-11-21
Medtronic Vascular Inc.
IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter2019-11-21
MEDTRONIC Inc.
Micra MC1VR01 Transcatheter Pacing System (TPS)2019-11-20
MEDTRONIC VASCULAR INC
EverFlex Self-Expanding Peripheral Stent Systems and EverFlex Self-Expanding Peripheral Stent with Entrust Delivery Syst2019-11-20
MEDTRONIC Inc.
MiniMed 530G System2019-11-15
MEDTRONIC MINIMED
iPro2 CGM System2019-11-15
MEDTRONIC MINIMED
Paradigm Real-Tme Revel System2019-11-15
MEDTRONIC MINIMED
Guardian Connect System2019-11-15
MEDTRONIC MINIMED
MiniMed 630G System2019-11-15
MEDTRONIC MINIMED, INC.
MiniMed 670G System2019-11-15
MEDTRONIC COREVALVE LLC
EnVeo Rand EnVeo PRO Delivery Catheter System of the CoreValve2019-11-13
Medtronic, Inc.
CareLink SmartSync Manager and MyCareLink Patient Monitor2019-11-12
MEDTRONIC COREVALVE LLC
CoreValve Evolut R System, CoreValve Evolut PRO System, and CoreValve Evolut PRO + System2019-11-07
MEDTRONIC Inc.
Medtronic MiniMed 530G System2019-11-04
MEDTRONIC MINIMED
Medtronic MiniMed 630G System2019-11-04
MEDTRONIC MINIMED
Guardian Connect System2019-11-04
MEDTRONIC MINIMED, INC.
Medtronic MiniMed 670G System2019-11-04
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI DR/VR ICD, Primo MRI DR/VR ICD, Prot2019-11-01
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia2019-11-01
MEDTRONIC Inc.
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR/SR MRI IPG, Astra S DR/SR MRI IPG, Astra XT DR/SR MRI IPG, Azure S D2019-11-01
MEDTRONIC Inc.
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola2019-11-01
MEDTRONIC Inc.
INFUSE Bone Graft2019-11-01
Medtronic Sofamor Danek USA, Inc.
INFUSE Bone Graft2019-11-01

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
Cardioblate™
MEDTRONIC, INC.2019-11-27
Cardioblate™
MEDTRONIC, INC.2019-11-27
Cardioblate™
MEDTRONIC, INC.2019-11-27
Cardioblate™
MEDTRONIC, INC.2019-11-27
CARDIOBLATE®
MEDTRONIC, INC.2019-11-27
CARDIOBLATE®
MEDTRONIC, INC.2019-11-27
CARDIOBLATE®
MEDTRONIC, INC.2019-11-27
CARDIOBLATE®
MEDTRONIC, INC.2019-11-27
CARDIOBLATE®
MEDTRONIC, INC.2019-11-27
ATAKR® II
MEDTRONIC, INC.2019-11-27
ATAKR™ II
MEDTRONIC, INC.2019-11-27
CARDIOBLATE®
MEDTRONIC, INC.2019-11-27
ATAKR™ II
MEDTRONIC, INC.2019-11-27
CARDIOBLATE®
MEDTRONIC, INC.2019-11-27
ATAKR™ II
MEDTRONIC, INC.2019-11-27
CARDIOBLATE® GEMINI®
MEDTRONIC, INC.2019-11-27
CARDIOBLATE® GEMINI®
MEDTRONIC, INC.2019-11-27
CARDIOBLATE®
MEDTRONIC, INC.2019-11-27
NA
MEDTRONIC, INC.2019-11-27
NA
MEDTRONIC, INC.2019-11-27
Cardioblate™ CryoFlex™
MEDTRONIC, INC.2019-11-25
Cardioblate™ CryoFlex™
MEDTRONIC, INC.2019-11-25
Cardioblate™ CryoFlex™
MEDTRONIC, INC.2019-11-25
MiniMed® 670G
MEDTRONIC MINIMED, INC.2019-11-25
MiniMed™ 630G
MEDTRONIC MINIMED, INC.2019-11-25
MiniMed™ 630G
MEDTRONIC MINIMED, INC.2019-11-25
MiniMed™ 630G
MEDTRONIC MINIMED, INC.2019-11-25
MiniMed™ 630G
MEDTRONIC MINIMED, INC.2019-11-25
NA
MEDTRONIC, INC.2019-11-25
NA
MEDTRONIC, INC.2019-11-25
NA
MEDTRONIC, INC.2019-11-25
NA
MEDTRONIC, INC.2019-11-25
NA
MEDTRONIC, INC.2019-11-25
NA
MEDTRONIC, INC.2019-11-25
NA
MEDTRONIC, INC.2019-11-20

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