Product code LWS ยท Class 3
Implantable Cardioverter Defibrillator (Non-Crt)
0510(k)s in 12 months (0 all time)
1recalls in 12 months (219 all time)
0recalls that name a 510(k)
Top companies in LWS
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2015 | Boston Scientific Corporation Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD).
Intended to provide defibrillation therapy. Terminated |
LWS | None listed |
| Sep 3, 2014 | St Jude Medical Cardiac Rhythm Management Division Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411
Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, Terminated |
LWS | None listed |
| Aug 5, 2014 | Boston Scientific CRM Corp Boston Scientific ENDOTAK RELIANCE SG, transvenous defibrillation lead, Models 0180 & 0292, Sterile EO.
Product Usage:
The ENDOTAK RELIANCE leads provide pacing and rate-sensing and deliver cardiover Terminated |
LWS | None listed |
| Aug 16, 2013 | Boston Scientific CRM Corp Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator. Terminated |
LWS | None listed |
| May 20, 2013 | Boston Scientific CRM Corp LATITUDE Patient Management System, Model 6488, Version 7.3.
The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Boston Scientific pulse generator and Terminated |
LWS | None listed |
| Mar 18, 2013 | Boston Scientific CRM Corp Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias. Terminated |
LWS | None listed |
| Apr 20, 2012 | Boston Scientific CRM Corp Boston Scientific LATITUDE Patient Management System Communicator, Model 6476, Distributed by Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, Made in Malaysia. The LATITUDE Pati Terminated |
LWS | None listed |
| Mar 22, 2012 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic EnTrust, Dual Chamber Implantable, Cardioverter Defibrillator with Ventricular Therapies, models D153DRG and D154DRG. The implantable cardioverter defibrillator is intended to provide ventr Terminated |
LWS | None listed |
| Mar 22, 2012 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic EnTrust, Single Chamber Implantable, Cardioverter Defibrillator with Ventricular Therapies, models D153VRC and D154VRC. The implantable cardioverter defibrillator is intended to provide ven Terminated |
LWS | None listed |
| Mar 22, 2012 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic EnTrust, Dual Chamber Implantable, Cardioverter Defibrillator with Atrial and Ventricular Therapies, models D153ATG and D154ATG. The device is indicated for use in ICD patients with atrial Terminated |
LWS | None listed |
| Mar 1, 2012 | Boston Scientific CRM Corp Boston Scientific, LATITUDE Patient Management System Communicator, Models 6476.
The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Guidant or Boston Terminated |
LWS | None listed |
| Feb 23, 2012 | Boston Scientific CRM Corp LATITUDE Patient management System, Model 6488, software version 7.2. It is indicated for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central Terminated |
LWS | None listed |
| Jan 11, 2012 | St Jude Medical CRMD St. Jude Medical Riata ST Silicone Endocardial Defibrillation Leads Riata(7Fr), Models: 7000, 7001, 7002, 7010, 7011, 7040, 7041, 7042
Product Usage: These Silicone transvenous high voltage (HV) le Terminated |
LWS | None listed |
| Jan 11, 2012 | St Jude Medical CRMD St. Jude Medical Riata (8Fr), Models: 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592
Product Usage: These Silicone transvenous high voltage (HV) leads connect an implantable Terminated |
LWS | None listed |
| Dec 1, 2011 | Boston Scientific CRM Corp LATITUDE Patient Management System, Models 6441*, 6442*, 6465*, 6488 (USA).
There are two software applications: the programmer software and the LATITUDE remote monitoring system software. The Model Terminated |
LWS | None listed |
| Oct 12, 2011 | Boston Scientific CRM Corp LATITUDE Paceart Integration Software, version 1.00 Model 6472.
LATITUDE Paceart Integration is software and therefore does not have any serial numbers. However, the software version affected is ver Terminated |
LWS | None listed |
| Sep 28, 2011 | Boston Scientific CRM Corp Boston Scientific, LATITUDE Patient Management System Communicator, Model 6476, Distributed by Boston Scientific, 4100 Hamline Avenue North, St Paul, MN 55112-5798
Boston Scientific, LATITUDE RF Terminated |
LWS | None listed |
| Sep 9, 2011 | Boston Scientific CRM Corp LATITUDE Patient Management System Communicator, Model 6482.
The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Boston Scientific pulse generator and Terminated |
LWS | None listed |
| Apr 26, 2011 | Boston Scientific CRM Corp Boston Scientific's LATITUDE Patient Management System:
LATITUDE 6.1 Patient Management System Website
Server software, Model 6488 for United States
Server software, Model 6465 for European Union
LA Terminated |
LWS | None listed |
| 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 |
| 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 |
| May 20, 2010 | Boston Scientific CRM Corp Boston Scientific, LATITUDE Communicator, Distributed by Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112. Models 6476 (USA) and 6468 (OUS) Terminated |
LWS | None listed |
| Nov 12, 2009 | Boston Scientific CRM Corp Guidant LATITUDE Communicator, model 6481, Boston Scientific 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. The LATITUDE Patient Management system enables physicians to periodically monitor Terminated |
LWS | None listed |
| 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 |
| Aug 18, 2009 | Medtronic 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 |
LWS | None listed |
| Aug 18, 2009 | Medtronic 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 |
LWS | None listed |
| Apr 8, 2009 | Medtronic 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 |
LWS | None listed |
| Jan 28, 2009 | Medtronic Inc. Cardiac Rhythm Managment Medtronic Maximo II VR D284VRC, for ventricular pacing and defibrillation. Terminated |
LWS | None listed |
| Jan 28, 2009 | Medtronic Inc. Cardiac Rhythm Managment Medtronic Maximo II DR D28DRG, for ventricular pacing and defibrillation. Terminated |
LWS | None listed |
| Oct 25, 2007 | Medtronic 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 |
LWS | None listed |
| Oct 25, 2007 | Medtronic 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 |
LWS | None listed |
| Oct 25, 2007 | Medtronic 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 |
LWS | None listed |
| Oct 25, 2007 | Medtronic 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 |
LWS | None listed |
| Oct 12, 2006 | Guidant Corporation Guidant Zoom Latitude Programming System, Model 3120, Programmer/Recorder/Monitor (PRM). A portable cardiac rhythm management system designed to be used with Guidant implantable pulse generators. Gu Terminated |
LWS | None listed |
| Nov 16, 2005 | St Jude Medical Atlas DR, Models V-240 Terminated |
LWS | None listed |
| Nov 16, 2005 | St Jude Medical Atlas VR, Models V-199 Terminated |
LWS | None listed |
| Nov 16, 2005 | St Jude Medical Photo Micro VR/DR Models V-194 Terminated |
LWS | None listed |
| Nov 16, 2005 | St Jude Medical Photo DR, Model V-230HV
Implantable Cardioverter Defibrillator Terminated |
LWS | None listed |
| May 6, 2005 | ela Medical Llc Sentinel Implantable Carioverter-DefibrilIator (ICD) model 2012 is a multi-programmable, two-zone, tiered-therapy device that incorporates anti-tachycardia pacing (ATP), cardioversion, and defibrillat Terminated |
LWS | None listed |
| May 6, 2005 | ela Medical Llc Sentinel Implantable Carioverter-DefibrilIator (ICD) model 2010 is a multi-programmable, two-zone, tiered-therapy device that incorporates anti-tachycardia pacing (ATP), cardioversion, and defibrillat Terminated |
LWS | None listed |
| Mar 11, 2005 | Medtronic 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 |
LWS | None listed |
| Mar 11, 2005 | Medtronic 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 |
LWS | None listed |
| Mar 11, 2005 | Medtronic 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 |
LWS | None listed |
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