ClearanceBrief
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

CodeDeviceRecords
LWPImplantable Pulse Generator, Pacemaker (Non-Crt)41
LWSImplantable Cardioverter Defibrillator (Non-Crt)14
NIKDefibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)12
KRGProgrammer, Pacemaker3
NKEPulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
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
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
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
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 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
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
Oct 7, 2010Boston 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
KRGNone 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 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
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
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
NIKNone listed
May 8, 2010Boston 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
KRGNone 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
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
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
Jul 11, 2007Boston 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
NIKNone listed
Jul 11, 2007Boston 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
NIKNone listed
Jul 11, 2007Boston 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
NIKNone listed
Jul 11, 2007Boston 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
NIKNone listed
Jul 11, 2007Boston 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
NIKNone listed
Jul 11, 2007Boston 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
NIKNone listed

Newest 50 of 71.

Get alerts for these product codes