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
| Code | Device | Records |
|---|---|---|
| LWS | Implantable Cardioverter Defibrillator (Non-Crt) | 10 |
| DXY | Implantable Pacemaker Pulse-Generator | 7 |
| NIK | Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) | 7 |
| NVZ | Pulse Generator, Permanent, Implantable | 5 |
| DTB | Permanent Pacemaker Electrode | 1 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 1 |
| LWP | Implantable Pulse Generator, Pacemaker (Non-Crt) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 26, 2010 | Medtronic 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 |
LWS | None listed |
| Nov 26, 2010 | Medtronic 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 |
LWS | None listed |
| Nov 22, 2010 | Medtronic Inc. Cardiac Rhythm Disease Managment Medtronic Dual Chamber Temporary Pacemaker, model 5388. Manufacturer: Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604, USA. Terminated |
LWP | None listed |
| Oct 21, 2010 | Medtronic 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 |
NIK | None listed |
| Oct 21, 2010 | Medtronic 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 |
NIK | None listed |
| Oct 21, 2010 | Medtronic 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 |
LWS | None listed |
| Oct 21, 2010 | Medtronic 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 |
LWS | None listed |
| Oct 21, 2010 | Medtronic 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 |
LWS | None listed |
| Oct 21, 2010 | Medtronic 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 |
LWS | None listed |
| Oct 21, 2010 | Medtronic 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 |
NIK | None listed |
| Oct 21, 2010 | Medtronic 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 |
NIK | None listed |
| Oct 21, 2010 | Medtronic 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 |
NIK | None listed |
| Aug 11, 2010 | Medtronic 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 |
NVZ | None listed |
| May 4, 2010 | Medtronic 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 |
JPA | None listed |
| Apr 26, 2010 | Medtronic 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 |
DXY | None listed |
| Mar 23, 2010 | Medtronic 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 |
DTB | K902002 |
| Nov 9, 2009 | Medtronic 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 |
LWS | None listed |
| Nov 9, 2009 | Medtronic 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 |
LWS | None listed |
| Nov 9, 2009 | Medtronic 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 |
LWS | None listed |
| Nov 9, 2009 | Medtronic 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 |
LWS | None listed |
| Nov 9, 2009 | Medtronic 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 |
NIK | None listed |
| Nov 9, 2009 | Medtronic 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 |
NIK | None listed |
| Jun 11, 2009 | Medtronic 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 |
NVZ | None listed |
| Jun 11, 2009 | Medtronic Inc. Cardiac Rhythm Disease Managment Medtronic SIGMA 100/200/300 Series IPGs, Single Chamber Pacemaker, model SVVI103, for ventricular use only. Terminated |
DXY | None listed |
| Jun 11, 2009 | Medtronic Inc. Cardiac Rhythm Disease Managment Medtronic SIGMA 100/200/300 Series IPGs, Dual Chamber atrial sensing, ventricular sensing and pacing Pacemaker, model SVDD303. Terminated |
DXY | None listed |
| Jun 11, 2009 | Medtronic Inc. Cardiac Rhythm Disease Managment Medtronic SIGMA 100/200/300 Series IPGs, Dual Chamber Rate Responsive Pacemaker, models DR353, SDR203, SDR303, and SDR306. Terminated |
DXY | None listed |
| Jun 11, 2009 | Medtronic 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 |
NVZ | None listed |
| Jun 11, 2009 | Medtronic Inc. Cardiac Rhythm Disease Managment Medtronic SIGMA 100/200/300 Series IPGs, Dual Chamber Pacemaker, models SD203 and SD303. Terminated |
DXY | None listed |
| Jun 11, 2009 | Medtronic Inc. Cardiac Rhythm Disease Managment Medtronic KAPPA 600/700/900 Series Implantable Pulse Generator (IPGs), Dual Chamber Pacemaker, models KD701, KD703, and KD706. Terminated |
NVZ | None listed |
| Jun 11, 2009 | Medtronic Inc. Cardiac Rhythm Disease Managment Medtronic SIGMA 100/200/300 Series IPGs, Single Chamber Rate Responsive Pacemaker; models SR353, SSR203, SSR303, and SSR306. Terminated |
DXY | None listed |
| Jun 11, 2009 | Medtronic 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 |
NVZ | None listed |
| Jun 11, 2009 | Medtronic Inc. Cardiac Rhythm Disease Managment Medtronic SIGMA 100/200/300 Series IPGs, Single Chamber Pacemaker; models SS103, SS106, SS203, and SS303. Terminated |
DXY | None listed |