ClearanceBrief
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)
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Top companies in LWS

DateFirm and productCodeLinked 510(k)
Nov 6, 2015Boston Scientific Corporation
Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). Intended to provide defibrillation therapy.
Terminated
LWSNone listed
Sep 3, 2014St 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
LWSNone listed
Aug 5, 2014Boston 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
LWSNone listed
Aug 16, 2013Boston Scientific CRM Corp
Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator.
Terminated
LWSNone listed
May 20, 2013Boston 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
LWSNone listed
Mar 18, 2013Boston 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
LWSNone listed
Apr 20, 2012Boston 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
LWSNone listed
Mar 22, 2012Medtronic 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
LWSNone listed
Mar 22, 2012Medtronic 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
LWSNone listed
Mar 22, 2012Medtronic 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
LWSNone listed
Mar 1, 2012Boston 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
LWSNone listed
Feb 23, 2012Boston 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
LWSNone listed
Jan 11, 2012St 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
LWSNone listed
Jan 11, 2012St 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
LWSNone listed
Dec 1, 2011Boston 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
LWSNone listed
Oct 12, 2011Boston 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
LWSNone listed
Sep 28, 2011Boston 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
LWSNone listed
Sep 9, 2011Boston 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
LWSNone listed
Apr 26, 2011Boston 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
LWSNone listed
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
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
May 20, 2010Boston 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
LWSNone listed
Nov 12, 2009Boston 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
LWSNone listed
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
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
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
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
Oct 12, 2006Guidant 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
LWSNone listed
Nov 16, 2005St Jude Medical
Atlas DR, Models V-240
Terminated
LWSNone listed
Nov 16, 2005St Jude Medical
Atlas VR, Models V-199
Terminated
LWSNone listed
Nov 16, 2005St Jude Medical
Photo Micro VR/DR Models V-194
Terminated
LWSNone listed
Nov 16, 2005St Jude Medical
Photo DR, Model V-230HV Implantable Cardioverter Defibrillator
Terminated
LWSNone listed
May 6, 2005ela 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
LWSNone listed
May 6, 2005ela 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
LWSNone 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 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

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