ClearanceBrief
Company

Medtronic Inc. Cardiac Rhythm Managment

FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.

0510(k) clearances (0 in 12 months)
34recalls (0 in 12 months)
5recalls that name a 510(k)

Product codes

CodeDeviceRecords
LWSImplantable Cardioverter Defibrillator (Non-Crt)15
DXYImplantable Pacemaker Pulse-Generator6
NIKDefibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)5
DPSElectrocardiograph2
DQYCatheter, Percutaneous2
NVZPulse Generator, Permanent, Implantable2
DTATester, Pacemaker Electrode Function1
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Aug 18, 2009Medtronic Inc. Cardiac Rhythm Managment
Medtronic Virtuoso VR, Model D154VWC, Single Chamber implantable cardioverter defibrillator with atrial therapies. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. This devic
Terminated
LWSNone listed
Aug 18, 2009Medtronic Inc. Cardiac Rhythm Managment
Medtronic Virtuoso DR, Model D154AWG, Dual Chamber implantable cardioverter defibrillator with atrial and ventricular therapies. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 US
Terminated
LWSNone listed
Apr 8, 2009Medtronic Inc. Cardiac Rhythm Managment
Medtronic RV Lead Integrity Alert , Cat. # SW012, 1.0 software in EnTrust(R) (D153ATG, D153VRC, D154ATG, D154VRC) and EnTrust(R) Escudo (D144DRG, D144VRC) defibrillators.
Terminated
LWSNone listed
Jan 28, 2009Medtronic Inc. Cardiac Rhythm Managment
Maximo II CRT D284TRK, for ventricular pacing and defibrillation.
Terminated
NIKNone listed
Jan 28, 2009Medtronic Inc. Cardiac Rhythm Managment
Medtronic Maximo II VR D284VRC, for ventricular pacing and defibrillation.
Terminated
LWSNone listed
Jan 28, 2009Medtronic Inc. Cardiac Rhythm Managment
Medtronic Maximo II DR D28DRG, for ventricular pacing and defibrillation.
Terminated
LWSNone listed
Sep 30, 2008Medtronic Inc. Cardiac Rhythm Managment
Medtronic Attain ACCESS 6218A, Left-heart delivery system. Sterilized. Manufactured in: Medtronic Ireland, Parkmore Business Park West, Galway, Ireland. Medtronic, Inc., 710 Medtronic Parkway, Mi
Terminated
DQYK021589
Sep 30, 2008Medtronic Inc. Cardiac Rhythm Managment
Medtronic Attain LDS 6216A, Left-heart delivery system. Sterilized. Manufactured in: Medtronic Ireland, Parkmore Business Park West, Galway, Ireland. Medtronic, Inc., 710 Medtronic Parkway, Minnea
Terminated
DQYK021587
Sep 30, 2008Medtronic Inc. Cardiac Rhythm Managment
Medtronic Adjustable Valve, 6248VAL, Sterilized using irradiation. Medtronic, Inc. Minneapolis, MN 55432, USA. The Medtronic model 6248VAL adjustable valve is an accessory designed for use with Med
Terminated
DTLK052459
Nov 6, 2007Medtronic Inc. Cardiac Rhythm Managment
Medtronic Paceart System, 2006 Edition, Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. The Paceart System can act as a Practice Management software application and is intende
Terminated
DPSK024278
Oct 25, 2007Medtronic Inc. Cardiac Rhythm Managment
Medtronic Sprint Fidelis 6949 Steroid eluting, quadripolar, screw-in, ventricular lead with right ventricular (RV) / Superior Vena Cava (SVC) defibrillation coil electrodes. Sterile. This lead is d
Terminated
LWSNone listed
Oct 25, 2007Medtronic Inc. Cardiac Rhythm Managment
Medtronic Sprint Fidelis 6948 Steroid eluting, quadripolar, ventricular lead with tined tip and right ventricular (RV) / Superior Vena Cava (SVC) defibrillation coil electrodes. Sterile. This lead
Terminated
LWSNone listed
Oct 25, 2007Medtronic Inc. Cardiac Rhythm Managment
Medtronic Sprint Fidelis 6931 Steroid eluting, tripolar, screw-in, ventricular lead with right ventricular (RV) defibrillation coil electrode. Sterile. This lead is designed for pacing, sensing, ca
Terminated
LWSNone listed
Oct 25, 2007Medtronic Inc. Cardiac Rhythm Managment
Medtronic Sprint Fidelis 6930 Steroid eluting, tripolar, ventricular lead with tined tip and right ventricular (RV) defibrillation coil electrode. Sterile. This lead is designed for pacing, sensing
Terminated
LWSNone listed
Jul 7, 2007Medtronic Inc. Cardiac Rhythm Managment
Vitatron T-Series Dual Chamber pacemaker T60 DR, model T60A1. The Vitatron C60 DR is a dual chamber rate responsive pacemaker (activity sensing using an accelerometer) for permanent atrial and ventric
Terminated
NVZNone listed
Jul 7, 2007Medtronic Inc. Cardiac Rhythm Managment
Vitatron C-Series C60DR DDDR Dual Chamber Rate Responsive Pacemaker includes the following models: C60A1 and C60A3. The Vitatron C60 DR is a dual chamber rate responsive pacemaker (activity sensing u
Terminated
NVZNone listed
May 31, 2006Medtronic Inc. Cardiac Rhythm Managment
Medtronic Paceart 2004 Second Edition & Paceart 2005 First Edition versions of the Paceart Gateway Software. The Medtronic Paceart System is a personal computer based pacemaker-testing system, a 12-l
Terminated
DPSK024278
Feb 18, 2006Medtronic Inc. Cardiac Rhythm Managment
Sigma implantable pulse generators (IPGs) Single Chamber Pacemaker model SVVI103, for ventricular use only.
Terminated
DXYNone listed
Feb 18, 2006Medtronic Inc. Cardiac Rhythm Managment
Sigma implantable pulse generators (IPGs) Single Chamber Rate Responsive Pacemaker, models SSR203, SSR303, SSR306
Terminated
DXYNone listed
Feb 18, 2006Medtronic Inc. Cardiac Rhythm Managment
Sigma implantable pulse generators (IPGs) Single Chamber Pacemaker, models SS103, SS106, SS203, SS303
Terminated
DXYNone listed
Feb 18, 2006Medtronic Inc. Cardiac Rhythm Managment
Sigma implantable pulse generators (IPGs) Dual Chamber Atrial Sensing, Ventricular Sensing and Pacing Pacemaker. Atrial Bipolar sensing connector, ventricular Bipolar connector, model SVDD303.
Terminated
DXYNone listed
Feb 18, 2006Medtronic Inc. Cardiac Rhythm Managment
Sigma implantable pulse generators (IPGs) Dual Chamber Rate Responsive Pacemaker, models SDR203, SDR303, SDR306
Terminated
DXYNone listed
Feb 18, 2006Medtronic Inc. Cardiac Rhythm Managment
Sigma implantable pulse generators (IPGs) dual Chamber Pacemaker, models SD203, SD303
Terminated
DXYNone listed
Mar 11, 2005Medtronic Inc. Cardiac Rhythm Managment
Medtronic InSync II Marquis, model 7289 Dual Chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy devices are tiered therapy implantable arrhythmia control devic
Terminated
NIKNone listed
Mar 11, 2005Medtronic Inc. Cardiac Rhythm Managment
Medtronic InSync III Protect, model 7285 Dual Chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy devices are tiered therapy implantable arrhythmia control devi
Terminated
NIKNone listed
Mar 11, 2005Medtronic Inc. Cardiac Rhythm Managment
Medtronic InSync III Marquis, model 7279 Dual Chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy devices are tiered therapy implantable arrhythmia control devi
Terminated
NIKNone listed
Mar 11, 2005Medtronic Inc. Cardiac Rhythm Managment
Medtronic Maximo DR, model 7278 Single Chamber Implantable Cardioverter Defibrillator (ICD)devices are tiered therapy implantable arrhythmia control devices, which provide automatic detection of ventr
Terminated
LWSNone listed
Mar 11, 2005Medtronic Inc. Cardiac Rhythm Managment
Medtronic InSync Marquis, model 7277 Dual Chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy devices are tiered therapy implantable arrhythmia control devices,
Terminated
NIKNone listed
Mar 11, 2005Medtronic Inc. Cardiac Rhythm Managment
Medtronic Marquis DR, model 7274 Dual Chamber Implantable Cardioverter Defibrillator (ICD) devices are tiered therapy implantable arrhythmia control devices, which provide automatic detection of ventr
Terminated
LWSNone listed
Mar 11, 2005Medtronic Inc. Cardiac Rhythm Managment
Medtronic Maximo VR, model 7232 Single Chamber Implantable Cardioverter Defibrillator (ICD)devices are tiered therapy implantable arrhythmia control devices, which provide automatic detection of ventr
Terminated
LWSNone listed
Mar 11, 2005Medtronic Inc. Cardiac Rhythm Managment
Medtronic Marquis VR, model 7230 Single Chamber Implantable Cardioverter Defibrillator (ICD)devices are tiered therapy implantable arrhythmia control devices, which provide automatic detection of vent
Terminated
LWSNone listed
Nov 17, 2004Medtronic Inc. Cardiac Rhythm Managment
Medtronic CapSureFix Novus Lead Model 5076.
Terminated
DTANone listed
Jul 20, 2004Medtronic Inc. Cardiac Rhythm Managment
Medtronic GEM DR Implantable Cardioverter Defibrillators, Model 7271
Terminated
LWSNone listed
Jul 20, 2004Medtronic Inc. Cardiac Rhythm Managment
Medtronic Micro Jewel II Implantable Cardioverter Defibrillators, Model 7223Cx
Terminated
LWSNone listed
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