ClearanceBrief
Company

Medtronic Inc. Cardiac Rhythm Disease 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)
32recalls (0 in 12 months)
1recalls that name a 510(k)

Product codes

CodeDeviceRecords
LWSImplantable Cardioverter Defibrillator (Non-Crt)10
DXYImplantable Pacemaker Pulse-Generator7
NIKDefibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)7
NVZPulse Generator, Permanent, Implantable5
DTBPermanent Pacemaker Electrode1
JPASystem, Multipurpose For In Vitro Coagulation Studies1
LWPImplantable Pulse Generator, Pacemaker (Non-Crt)1

Latest 510(k) clearances

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

Latest recalls

DateFirm and productCodeLinked 510(k)
Nov 26, 2010Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic Sprint Quattro Secure, model 6947. Steroid eluting, quadripolar, screw-in, ventricular lead with Right Ventricular (RV) and superior vena cava (SVC) defibrillation coil electrodes. Content
Terminated
LWSNone listed
Nov 26, 2010Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic Sprint Quattro Secure S, model 6935. Steroid eluting, tripolar, screw-in, ventricular lead with RV defibrillation coil electrode. Contents Sterile. Manufactured in: Villalba, Puerto Rico
Terminated
LWSNone listed
Nov 22, 2010Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic Dual Chamber Temporary Pacemaker, model 5388. Manufacturer: Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604, USA.
Terminated
LWPNone listed
Oct 21, 2010Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic Virtuoso II VR, model D274VRC, and model D294VRC not available in the U.S.. Digital Single chamber implantable cardioverter defibrillator (VVE-VVIR). Sterilized using ethylene oxide. Medt
Terminated
NIKNone listed
Oct 21, 2010Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic Virtuoso II DR, model D274DRG, and model D294DRG not available in the U.S.. Digital Dual chamber implantable cardioverter defibrillator (DDE-DDDR). Sterilized using ethylene oxide. Medtro
Terminated
NIKNone listed
Oct 21, 2010Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic Secura VR, model D224VRC, and model D234VRC not available in the U.S.. Digital single chamber implantable cardioverter defibrillator (VVE-VVIR). Sterilized using ethylene oxide. Medtronic
Terminated
LWSNone listed
Oct 21, 2010Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic Secura DR, model D224DRG, and model D234DRG not available in the U.S.. Digital Dual chamber implantable cardioverter defibrillator (DDE-DDDR). Sterilized using ethylene oxide. Medtronic,
Terminated
LWSNone listed
Oct 21, 2010Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic Maximo II VR, model D284VRC. Digital single chamber implantable cardioverter defibrillator (VVE-VVIR). Sterilized using ethylene oxide. Medtronic, Inc., Minneapolis, MN 55432 USA. Manu
Terminated
LWSNone listed
Oct 21, 2010Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic Maximo II DR, model D284DRG. Digital dual chamber implantable cardioverter defibrillator (VVE-DDDR). Sterilized using ethylene oxide. Medtronic, Inc., Minneapolis, MN 55432 USA. Manufa
Terminated
LWSNone listed
Oct 21, 2010Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic Maximo II CRT-D, model D284TRK. Digital implantable cardioverter defibrillator with cardiac resynchronization therapy (VVE-DDDR). Sterilized using ethylene oxide. Medtronic, Inc., Minneap
Terminated
NIKNone listed
Oct 21, 2010Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic Consulta CRT-D, model D224TRK and Model D234TRK not available in the US. Digital implantable cardioverter defibrillator with cardiac resynchronization therapy (DDE-DDDR). Sterilized using
Terminated
NIKNone listed
Oct 21, 2010Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic Concerto II CRT-D, model D274TRK and Model D294TRK not available in the US. Digital implantable cardioverter defibrillator with cardiac resynchronization therapy (DDE-DDR). Sterilized usi
Terminated
NIKNone listed
Aug 11, 2010Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic Carelink Monitor Model 2490C. The Medtronic CareLink Monitor Model 2490C is designed to automatically gather information from the implanted heart device. This automatic wireless communicatio
Terminated
NVZNone listed
May 4, 2010Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic HMS PLUS, Hemostasis Management System. Medtronic, Inc., Cardiovascular Division, Moundsview, MN 55112. A microprocessor based, multichannel clot timing instrument with automated syringe h
Terminated
JPANone listed
Apr 26, 2010Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic EnRhythm, P1501DR, Dual Chamber Rate Responsive Pacemaker with RapidRead Telemetry. The EnRhythm pacing system is an implantable medical device that monitors, detects, and treats atrial ta
Terminated
DXYNone listed
Mar 23, 2010Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic, Sutureless, unipolar, myocardial, screw-in pacing lead, 5071-15, 5071-25, 5071-35 & 5071-53, Medtronic, Inc., Minneapolis, MN 55432, Manufactured in: Villalba, Puerto Rico.
Terminated
DTBK902002
Nov 9, 2009Medtronic Inc. Cardiac Rhythm Disease Managment
This device is not approved in the United States. Medtronic Virtuoso VR, D164VWC. Medtronic, Inc., Minneapolis, MN 55432 USA.
Terminated
LWSNone listed
Nov 9, 2009Medtronic Inc. Cardiac Rhythm Disease Managment
This device is not approved in the United States. Medtronic Virtuoso DR, D164AWG. Medtronic, Inc., Minneapolis, MN 55432 USA.
Terminated
LWSNone listed
Nov 9, 2009Medtronic Inc. Cardiac Rhythm Disease 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 device i
Terminated
LWSNone listed
Nov 9, 2009Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic Virtuoso DR, D154AWG, Dual Chamber implantable cardioverter defibrillator with atrial and ventricular therapies. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. This
Terminated
LWSNone listed
Nov 9, 2009Medtronic Inc. Cardiac Rhythm Disease Managment
This device is not approved in the United States. Medtronic Concerto, C174AWK. Dual Chamber implantable cardioverter defibrillator with cardiac resynchronization therapy, atrial and ventricular thera
Terminated
NIKNone listed
Nov 9, 2009Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic Concerto, C154DWK, Dual chamber implantable cardioverter defibrillator with cardiac resynchronization therapy, atrial and ventricular therapies. Medtronic, Inc., Minneapolis, MN 55432 USA.
Terminated
NIKNone listed
Jun 11, 2009Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic KAPPA 600/700/900 Series Implantable Pulse Generator (IPGs), Dual Chamber atrial sensing, ventricular sensing and pacing Pacemaker, models KVDD701 and KVDD901.
Terminated
NVZNone listed
Jun 11, 2009Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic SIGMA 100/200/300 Series IPGs, Single Chamber Pacemaker, model SVVI103, for ventricular use only.
Terminated
DXYNone listed
Jun 11, 2009Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic SIGMA 100/200/300 Series IPGs, Dual Chamber atrial sensing, ventricular sensing and pacing Pacemaker, model SVDD303.
Terminated
DXYNone listed
Jun 11, 2009Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic SIGMA 100/200/300 Series IPGs, Dual Chamber Rate Responsive Pacemaker, models DR353, SDR203, SDR303, and SDR306.
Terminated
DXYNone listed
Jun 11, 2009Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic KAPPA 600/700/900 Series Implantable Pulse Generator (IPGs), Dual Chamber Rate Responsive Pacemaker, models KDR601, KDR603, KDR606, KDR651, KDR653, KDR701, KDR703, KDR706, KDR721, and KDR921
Terminated
NVZNone listed
Jun 11, 2009Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic SIGMA 100/200/300 Series IPGs, Dual Chamber Pacemaker, models SD203 and SD303.
Terminated
DXYNone listed
Jun 11, 2009Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic KAPPA 600/700/900 Series Implantable Pulse Generator (IPGs), Dual Chamber Pacemaker, models KD701, KD703, and KD706.
Terminated
NVZNone listed
Jun 11, 2009Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic SIGMA 100/200/300 Series IPGs, Single Chamber Rate Responsive Pacemaker; models SR353, SSR203, SSR303, and SSR306.
Terminated
DXYNone listed
Jun 11, 2009Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic KAPPA 600/700/900 Series Implantable Pulse Generator (IPGs), Single Chamber Rate Responsive Pacemaker; models KSR701, KSR703, KSR706, KSR901, KSR903, and KSR906.
Terminated
NVZNone listed
Jun 11, 2009Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic SIGMA 100/200/300 Series IPGs, Single Chamber Pacemaker; models SS103, SS106, SS203, and SS303.
Terminated
DXYNone listed
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