Company
Boston Scientific CRM Corp
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)
71recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LWP | Implantable Pulse Generator, Pacemaker (Non-Crt) | 41 |
| LWS | Implantable Cardioverter Defibrillator (Non-Crt) | 14 |
| NIK | Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) | 12 |
| KRG | Programmer, Pacemaker | 3 |
| NKE | Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) | 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) |
|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 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 |
| 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 |
| Oct 7, 2010 | Boston Scientific CRM Corp Guidant, Vitality HE ICD, Model: T180DDR, Sterile Lot, Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798. Terminated |
KRG | 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 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 |
| 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 CONTAK RENEWAL 3 (Models H170), Guidant CONTAK RENEWAL 3 HE (Models H177, H179). Cardiac Resynchronization Therapy Defibrillator (CRT-D). These CRT-Ds provide ventricular tachyarrhythmia and cardiac Terminated |
NIK | None listed |
| May 8, 2010 | Boston Scientific CRM Corp VITALITY Implantable Cardioverter Defibrillator. Atrial and Ventricular Therapies. AVT, model A155. VITALITY DS DR/VR (Models T125, T135), VITALITY 2 DR/VR (Models T165, T175) and VITALITY 2 EL Terminated |
KRG | 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 |
| 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 |
| 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 |
| Jul 11, 2007 | Boston Scientific CRM Corp VITALITY 2 EL DR/VR (model T167, T177). contents have been sterilized with gaseous ethylene oxide. The Guidant Vitality 2 ICD, implantable cardioverter defibrillators, are designed to detect and ter Terminated |
NIK | None listed |
| Jul 11, 2007 | Boston Scientific CRM Corp VITALITY DR HE Implantable Cardioverter Defibrillator (model T180). Sterile EO. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. This ICD is desi Terminated |
NIK | None listed |
| Jul 11, 2007 | Boston Scientific CRM Corp VITALITY 2 (model T165, T175), VITALITY DS (model T125, T135), VITALITY EL (model T127), Implantable Cardioverter Defibrillators (ICD), are designed to detect and terminate ventricular tachycardia (VT Terminated |
NIK | None listed |
| Jul 11, 2007 | 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, Terminated |
NIK | None listed |
| Jul 11, 2007 | Boston Scientific CRM Corp These models are not available in the US. CONTACT RENEWAL 4 AVT HE (model number M170, M175, M177, M179). Cardiac Resynchronization Therapy Defibrillator. Guidant Corporation Cardiac Rhythm Managemen Terminated |
NIK | None listed |
| Jul 11, 2007 | Boston Scientific CRM Corp These models are not available in the US. Guidant CONTAK RENEWAL 4 RF/HE (model H230, H235) Guidant CONTAK RENEWAL 4 RF HE (model H239 ) cardiac resynchronization therapy defibrillator (CRT-D). Terminated |
NIK | None listed |
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