Product code LWP ยท Class 3
Implantable Pulse Generator, Pacemaker (Non-Crt)
0510(k)s in 12 months (0 all time)
1recalls in 12 months (113 all time)
0recalls that name a 510(k)
Top companies in LWP
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 7, 2017 | Boston Scientific Corporation ACCOLADE EL DR Pacemaker Open, Classified |
LWP | None listed |
| Dec 7, 2017 | Boston Scientific Corporation ACCOLADE DR Pacemaker Open, Classified |
LWP | None listed |
| Dec 7, 2017 | Boston Scientific Corporation ACCOLADE SR Pacemaker Open, Classified |
LWP | None listed |
| Aug 28, 2017 | St Jude Medical Inc. PM1226 ACCENT ST MRI SR RF and PM2222 ACCENT ST
These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply an Terminated |
LWP | None listed |
| Nov 30, 2016 | Boston Scientific Corporation Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly. Terminated |
LWP | None listed |
| Sep 7, 2016 | Boston Scientific Corporation Pacemakers: Accolade MRI DR Model L311; Accolade MRI DR EL Model L331; and Essentio MRI DR Model L111.
These pulse generators provide bradycardia pacing and adaptive rate pacing to detect and trea Terminated |
LWP | None listed |
| Jan 8, 2016 | Boston Scientific Corporation Boston Scientific, PROPONENT" MRI DR Pacemakers, REF L211.
These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary. Terminated |
LWP | None listed |
| Jan 8, 2016 | Boston Scientific Corporation Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker.
These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary Terminated |
LWP | None listed |
| Oct 18, 2014 | Boston Scientific CRM Corp Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene Terminated |
LWP | None listed |
| Oct 18, 2014 | Boston Scientific CRM Corp Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using et Terminated |
LWP | None listed |
| May 24, 2014 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generator (EPG) Temporary Pacemaker (AAI/VVI).
Used in conjunction with a cardiac pacing lead system for temporary atrial or Terminated |
LWP | None listed |
| Oct 17, 2013 | Boston Scientific CRM Corp Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scien Terminated |
LWP | None listed |
| Oct 17, 2013 | Boston Scientific CRM Corp Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using et Terminated |
LWP | 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 7, 2010 | Boston Scientific CRM Corp Guidant, CONTAK RENEWAL 3/3RF Models H170, H175, H177, H179, H210, H215, H217, H219, Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798
CONTAK RENEWAL 4/4RF Models H190*, H195* Terminated |
LWP | None listed |
| May 8, 2010 | Boston Scientific CRM Corp VENTAK PRIZM Automatic Implantable Cardioverter Defibrillator (AICD). DR, model 1851, DR HE, model 1853 and 1858, PRIZM VR HE, model 1857, PRIZM 2 VR model 1860 and PRIZM 2 DR model 1861. The ICDs a Terminated |
LWP | None listed |
| May 8, 2010 | Boston Scientific CRM Corp Boston Scientific LIVIAN Cardiac Resynchronization Therapy Defibrillator (CRT-D), models H220, H225, H227, H229. The LIVIAN family of cardiac resynchronization therapy defibrillators (CRT-Ds), provid Terminated |
LWP | None listed |
| May 8, 2010 | Boston Scientific CRM Corp Boston Scientific CONFIENT, model E030, Implantable Cardioverter Defibrillator (ICD). The CONFIENT Implantable Cardioverter Defibrillator (ICDs) are designed to detect and terminate ventricular tachy Terminated |
LWP | None listed |
| May 8, 2010 | Boston Scientific CRM Corp Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, Models N118 and N119. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 66112 Terminated |
LWP | None listed |
| May 8, 2010 | Boston Scientific CRM Corp Boston Scientific TELIGEN, Implantable Cardiac Defibrillator, Models E102 and E110. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 66112-5798, USA. The pro Terminated |
LWP | None listed |
| Jan 13, 2010 | Boston Scientific CRM Corp Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Sc Terminated |
LWP | None listed |
| Jan 13, 2010 | Boston Scientific CRM Corp Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. the following models are not available in the US: models N106, N107, P106, P107, P108. Sterilized Terminated |
LWP | None listed |
| Aug 18, 2009 | Boston Scientific CRM Corp Boston Scientific TELIGEN, Implantable Cardiac Defibrillator, Models E102 and E110. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 66112-5798, USA.
The Terminated |
LWP | None listed |
| Aug 18, 2009 | Boston Scientific CRM Corp Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, Models N118 and N119. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 66 Terminated |
LWP | None listed |
| Jul 17, 2009 | Boston Scientific CRM Corp GUIDANT VITALITY DS VR Model T135 VR; EL Model T127 DR; 2ICD Model T165 DR; 2ICD Model T175 VR; 2EL ICD Model T167 DR; 2 EL ICD Model T177 VR; DS Model T125 DR. Implantable Cardioverter Defibrillato Terminated |
LWP | None listed |
| Jul 17, 2009 | Boston Scientific CRM Corp Guidant Contak Renewal 3 CRT-D Model H170; 3CRT-D, Model H175; 3HE CRT-D, Model H177; 3HE CRT-D, Model H179; 4CRT-D REF H190; 4CRT-D REF H195; 4HE CRT-D REF H197; 4HE CRT-D REF H199; 4AVT CRT D, REF Terminated |
LWP | None listed |
| Jul 14, 2009 | Boston Scientific CRM Corp Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110. Terminated |
LWP | None listed |
| Jul 14, 2009 | Boston Scientific CRM Corp Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. the following models are not available in the US: models N106, N107, P106, P107. Terminated |
LWP | None listed |
| Aug 21, 2008 | Boston Scientific CRM Corp VITALITY EL, models T127, T167, T177 Implantable Cardioverter Defibrillator (ICD), pulse-generator, dual Chamber Terminated |
LWP | None listed |
| Aug 21, 2008 | Boston Scientific CRM Corp VITALITY DR+ Implantable Cardioverter Defibrillator (ICD), model 1872 Terminated |
LWP | None listed |
| Nov 24, 2007 | Boston Scientific CRM Corp Guidant CONTAK RENEWAL 3 AVT (Models M150, M155) Guidant CONTAK RENEWAL 3 AVT HE (Models M157, M159), Guidant CONTAK RENEWAL 4 AVT (Models M170, M175)*, Guidant CONTAK RENEWAL 4 AVT HE (Models M177 a Terminated |
LWP | None listed |
| Nov 24, 2007 | Boston Scientific CRM Corp Guidant CONTAK RENEWAL 3 (Models H170, H173, H175), Guidant CONTAK RENEWAL 3 HE (Models H177, H179). Guidant CONTAK RENEWAL 4 (Models H190,H195) *, Guidant CONTAK RENEWAL 4 HE (Models H197, H199)* Terminated |
LWP | None listed |
| Nov 24, 2007 | Boston Scientific CRM Corp Guidant VITALITY 2 DR/VR (Models T165, T175) and Guidant VITALITY 2 EL DR/VR (Models T167, T177). Implantable Cardioverter Defibrillator, ICD. Guidant Corporation, 4100 Hamline Avenue North, St. Pau Terminated |
LWP | None listed |
| Nov 24, 2007 | Boston Scientific CRM Corp Guidant VITALITY DS DR/VR (Models T125, T135), Guidant VITALITY EL (Model T127), Guidant VITALITY DR HE (Model T180), Implantable Cardioverter Defibrillators (ICD). Guidant Corporation, Cardiac Rhyth Terminated |
LWP | None listed |
| Nov 24, 2007 | Boston Scientific CRM Corp Guidant ASSURE, Model B301, Implantable Cardioverter Defibrillator, ICD. (This model is not available in the USA) Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, M Terminated |
LWP | None listed |
| Nov 24, 2007 | Boston Scientific CRM Corp Guidant VITALITY AVT, Models A135 and A155. Implantable Cardioverter Defibrillator, ICD. Atrial and Ventricular Therapies. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, Terminated |
LWP | None listed |
| Nov 24, 2007 | Boston Scientific CRM Corp Guidant VITALITY VR/DR, Implantable Cardioverter Defibrillator, ICD, Models 1870 and 1871. Guidant VITALITY DR+, Implantable Cardioverter Defibrillator, ICD, Model 1872. Terminated |
LWP | None listed |
| Dec 16, 2006 | Guidant Corporation Guidant CONTAK RENEWAL 3 RF (models H210, H215), CONTAK RENEWAL 3 RF HE (models H217, H219) ,CONTAK RENEWAL 4 RF (model H230), and CONTAK RENEWAL 4 RF HE (model H239) cardiac resynchronization therapy Terminated |
LWP | None listed |
| Sep 28, 2006 | Boston Scientific CRM Corp VITALITY (models 1870, 1871, T125, T127, T135) and VITALITY 2 (models T165, T167, T175, T177). Implantable Cardioverter Defibrillators (ICD). Quantities Distributed by model are as follows: VITALITY Terminated |
LWP | None listed |
| Sep 28, 2006 | Boston Scientific CRM Corp Guidant INSIGNIA I AVT --family of pacemakers includes the following: SSI (model 482), VDD (model 882), DDD (model 982), SR (model 1192 and DR (model 1292). Intermedics NEXUS I AVT family of pacemaker Terminated |
LWP | None listed |
| Sep 28, 2006 | Boston Scientific CRM Corp Guidant INSIGNIA I Plus --family of pacemakers includes the following: SR (models1194); and DR (models1297, 1298). Intermedics NEXUS I Plus family of pacemakers includes the following: DR (model 1467, Terminated |
LWP | None listed |
| Sep 28, 2006 | Boston Scientific CRM Corp Guidant INSIGNIA I Ultra --family of pacemakers includes the following: SR (models1190); and DR (models1290, 1291). Intermedics NEXUS I Ultra family of pacemakers includes the following: SR (model 139 Terminated |
LWP | None listed |
| Sep 28, 2006 | Boston Scientific CRM Corp Guidant INSIGNIA I Entra-- family of pacemakers includes the following: SSI (model numbers 0484 and 0485); DDD (models 0985, 0986); SR (models 1195, 1198); and DR (models1294, 1295, 1296). --Intermedi Terminated |
LWP | None listed |
| Jul 27, 2006 | Boston Scientific CRM Corp Guidant VITALITY 2 (models T165, T175), VITALITY DS (model T125), VITALITY EL (model T135), Implantable Cardioverter Defibrillators (ICD), are designed to detect and terminate ventricular tachycardia Terminated |
LWP | None listed |
| Jul 27, 2006 | Boston Scientific CRM Corp VITALITY AVT, model A155. Implantable Cardioverter Defibrillator. Atrial and Ventricular Therapies. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, U Terminated |
LWP | None listed |
| Jul 27, 2006 | Boston Scientific CRM Corp CONTACT RENEWAL 4 AVT HE model numbers M177. Cardiac Resynchronization Therapy Defibrillator. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA. CO Terminated |
LWP | None listed |
| Jul 4, 2006 | Guidant Corporation Guidant CONTAK RENEWAL 3 AVT (models M150, M155), CONTAK RENEWAL 3 AVT HE (models M157, M159), CONTAK RENEWAL 4 AVT (models M170, M175), CONTAK RENEWAL 4 AVT HE (models M177, M179). Cardiac Resynchro Terminated |
LWP | None listed |
| Jul 4, 2006 | Guidant Corporation VITALITY HE (model T180) Implantable Cardioverter Defibrillator (ICD). Sterile EO. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. This ICD is Terminated |
LWP | None listed |
| May 23, 2006 | Guidant Corporation VITALITY DS (model T125) and VITALITY 2 (models T165, 175) ICD (implantable cardiac defibrillator) Terminated |
LWP | None listed |
| Aug 16, 2005 | Boston Scientific CRM Corp CONTAK RENEWAL 3 AVT model numbers M150 and M155; CONTAK RENEWAL 3 AVT HE model numbers M157 and M159; CONTAK RENEWAL 4 AVT, model numbers M170 and M175; CONTAK RENEWAL 4 AVT HE model numbers M177 and Terminated |
LWP | None listed |
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