ClearanceBrief
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)
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Top companies in LWP

DateFirm and productCodeLinked 510(k)
Dec 7, 2017Boston Scientific Corporation
ACCOLADE EL DR Pacemaker
Open, Classified
LWPNone listed
Dec 7, 2017Boston Scientific Corporation
ACCOLADE DR Pacemaker
Open, Classified
LWPNone listed
Dec 7, 2017Boston Scientific Corporation
ACCOLADE SR Pacemaker
Open, Classified
LWPNone listed
Aug 28, 2017St 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
LWPNone listed
Nov 30, 2016Boston Scientific Corporation
Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly.
Terminated
LWPNone listed
Sep 7, 2016Boston 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
LWPNone listed
Jan 8, 2016Boston 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
LWPNone listed
Jan 8, 2016Boston 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
LWPNone listed
Oct 18, 2014Boston 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
LWPNone listed
Oct 18, 2014Boston 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
LWPNone listed
May 24, 2014Medtronic 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
LWPNone listed
Oct 17, 2013Boston 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
LWPNone listed
Oct 17, 2013Boston 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
LWPNone 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 7, 2010Boston 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
LWPNone listed
May 8, 2010Boston 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
LWPNone listed
May 8, 2010Boston 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
LWPNone listed
May 8, 2010Boston 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
LWPNone listed
May 8, 2010Boston 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
LWPNone listed
May 8, 2010Boston 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
LWPNone listed
Jan 13, 2010Boston 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
LWPNone listed
Jan 13, 2010Boston 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
LWPNone listed
Aug 18, 2009Boston 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
LWPNone listed
Aug 18, 2009Boston 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
LWPNone listed
Jul 17, 2009Boston 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
LWPNone listed
Jul 17, 2009Boston 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
LWPNone listed
Jul 14, 2009Boston 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
LWPNone listed
Jul 14, 2009Boston 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
LWPNone listed
Aug 21, 2008Boston Scientific CRM Corp
VITALITY EL, models T127, T167, T177 Implantable Cardioverter Defibrillator (ICD), pulse-generator, dual Chamber
Terminated
LWPNone listed
Aug 21, 2008Boston Scientific CRM Corp
VITALITY DR+ Implantable Cardioverter Defibrillator (ICD), model 1872
Terminated
LWPNone listed
Nov 24, 2007Boston 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
LWPNone listed
Nov 24, 2007Boston 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
LWPNone listed
Nov 24, 2007Boston 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
LWPNone listed
Nov 24, 2007Boston 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
LWPNone listed
Nov 24, 2007Boston 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
LWPNone listed
Nov 24, 2007Boston 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
LWPNone listed
Nov 24, 2007Boston 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
LWPNone listed
Dec 16, 2006Guidant 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
LWPNone listed
Sep 28, 2006Boston 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
LWPNone listed
Sep 28, 2006Boston 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
LWPNone listed
Sep 28, 2006Boston 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
LWPNone listed
Sep 28, 2006Boston 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
LWPNone listed
Sep 28, 2006Boston 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
LWPNone listed
Jul 27, 2006Boston 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
LWPNone listed
Jul 27, 2006Boston 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
LWPNone listed
Jul 27, 2006Boston 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
LWPNone listed
Jul 4, 2006Guidant 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
LWPNone listed
Jul 4, 2006Guidant 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
LWPNone listed
May 23, 2006Guidant Corporation
VITALITY DS (model T125) and VITALITY 2 (models T165, 175) ICD (implantable cardiac defibrillator)
Terminated
LWPNone listed
Aug 16, 2005Boston 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
LWPNone listed

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