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Boston Scientific

1,882 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
VIGOR DR/SR, DISCOVERY, and MERIDIAN (P940031/S079)Boston Scientific2021-04-02
VENTAK (P830060/S085)Boston Scientific2021-04-02
VENTAK P (P890061/S024)Boston Scientific2021-04-02
INGEVITY MRI Pace/Sense Leads (P150012/S108)Boston Scientific2021-04-02
DELTA/VISTA (P840068/S055)Boston Scientific2021-04-02
VENTAK PRx and VENTAK MINI (P910077/S183)Boston Scientific2021-04-02
VENTAK AV & VENTAK PRIZM DR/VR, VITALITY, CONFIENT, TELIGEN, PUNCTUA ICD, ENERGEN ICD, INCEPTA ICD, ORIGEN ICD, INOGEN I (P960040/S462)Boston Scientific2021-04-02
VENTAK P2 System (P930035/S031)Boston Scientific2021-04-02
SWEET TIP Rx, SWEET PICOTIO Rx, and FLEXTEND (P960006/S051)Boston Scientific2021-04-02
THINLINE/FINELINE Family of Endocardial Pacing Leads (P960004/S093)Boston Scientific2021-04-02
LATITUDE Programming System (P910077/S182)Boston Scientific2021-02-02
Ventak AV AICD, Ventak Prizm DR/VR, Vitality, Cofient, and Teligen Automatic Implantable Cardioveter Defibrillator Syste (P960040/S460)Boston Scientific2021-02-02
Imageready MR Conditional Pacing System and Ingevity PACE/SENSE Lead (P150012/S104)Boston Scientific2021-02-02
FINELINE™ II Sterox, Endocardial Pacing Lead, Passive Fixation (P960004/S092)Boston Scientific2021-01-13
INGEVITY™ non-MRI Lead Passive Fixation, Preformed Atrial J, INGEVITY™ non-MRI Lead Passive Fixation, Ventricular, INGEV (P150012/S106)Boston Scientific2021-01-13
Endotak Lead System (P910073/S159)Boston Scientific2021-01-13
FLEXTEND® Bipolar, Steroid Eluting, Extendable/Retractable Pacing Lead (P960006/S050)Boston Scientific2021-01-13
ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, and ACCOLADE MRI EL D (P150012/S105)Boston Scientific2020-12-11
Ventak AV AICD Ventak Prizm DR/VR, Vitality, Cofient, and Teligen Automatic Implantable Cardioverter Defibrillator Syste (P960040/S461)Boston Scientific2020-12-11
VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM (P960040/S456)Boston Scientific2020-12-04
ENDOTAK LEAD SYSTEM (P910073/S158)Boston Scientific2020-12-04
ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI (P150012/S103)Boston Scientific2020-11-16
VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM (P960040/S457)Boston Scientific2020-11-12
ICD ORIGEN VR, ICD ORIGEN DR, ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, MOMENTUM EL ICD VR, MOMENTUM (P960040/S458)Boston Scientific2020-11-05
TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA - ICD Device (P960040/S453)Boston Scientific2020-10-22
INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIOMRI, PROPONENT MRI, ACCOLADE MRI - Pacemaker Devices (P150012/S099)Boston Scientific2020-10-22
PG ACCOLADE MRI DR, PG ACCOLADE MRI SR, PG ESSENTIO MRI DR, PG ESSENTIO MRI SR, PG PROPONENT MRI DR, and PG PROPONENT M (P150012/S102)Boston Scientific2020-10-22
ICD AUTOGEN DR, ICD AUTOGEN VR, ICD DYNAGEN DR, ICD DYNAGEN VR, ICD INOGEN DR, ICD INOGEN VR, ICD ORIGEN DR, ICD ORIGEN (P960040/S455)Boston Scientific2020-10-22
LATITUDE™ NXT Patient Management System, LATITUDE™ Wave Communicator, LATITUDE™ Consult Communicator, LATITUDE™ NXT Syst (P910077/S180)Boston Scientific2020-10-22
ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI Pacemakers (P150012/S100)Boston Scientific2020-10-16
PG ESSENTIO MRI SR, PG ESSENTIO MRI DR, PG PROPONENT MRI SR, PG PROPONENT MRI DR, PG ACCOLADE MRI SR, PG ACCOLADE MRI D (P150012/S101)Boston Scientific2020-10-01
ICD ORIGEN VR, ICD ORIGEN DR, ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, ICD ORIGEN VR, ICD ORIGEN DR (P960040/S454)Boston Scientific2020-10-01
FINELINE II Steroid-Eluting Pacing Leads (P960004/S091)Boston Scientific2020-09-25
LATITUDE Programming System (Programmer) (P910077/S181)Boston Scientific2020-09-17
ESSENTIO, PROPONENT, ACCOLADE - MRI Pacemakers (P150012/S098)Boston Scientific2020-09-03
ImageReady MR Conditional Pacing System and INGEVITY Pace/Sense Lead (P150012/S096)Boston Scientific2020-08-26
ORIGEN, INOGEN, DYNAGEN MINI ICD VR/DR, ORIGEN, MOMENTUM, INOGEN, DYNAGEN, VIGILANT, RESONATE EL ICD VR/DR, ICD AUTOGEN, (P960040/S452)Boston Scientific2020-08-03
IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD (P150012/S097)Boston Scientific2020-08-03
LATITUDE Programming System (P910077/S178)Boston Scientific2020-07-07
RELIANCE 4-FRONT (P910073/S157)Boston Scientific2020-07-07
Imageready MR Conditional Pacing System and Ingevity Pace/Sense Lead (P150012/S095)Boston Scientific2020-06-19
IntellaNav XP and IntellaNav MiFi XP ablation catheters (P020025/S128)Boston Scientific2020-06-17
(Pacemaker Devices) INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S092)Boston Scientific2020-06-15
LATITUDE Programming System, Altrua/Insignia I/Nexus I (P910077/S177)Boston Scientific2020-06-15
(ICD Devices) TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIV (P960040/S450)Boston Scientific2020-06-15
LATITUDE Wave Communicators (P910077/S179)Boston Scientific2020-06-12
Blazer Prime HTD cardiac ablation catheter (P020025/S127)Boston Scientific2020-06-04
Blazer II XP Cardiac Ablation Catheter and Cable (P020025/S126)Boston Scientific2020-05-19
INGEVITY lead family (P150012/S094)Boston Scientific2020-05-04
INGEVITY MRI Lead and INGEVITY non-MRI Lead (P150012/S093)Boston Scientific2020-04-16
ICD ORIGEN VR, ICD ORIGEN DR, ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, ICD AUTOGEN VR, ICD AUTOGEN (P960040/S451)Boston Scientific2020-04-07
ICD Devices: TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT and PERC (P960040/S446)Boston Scientific2020-04-01
LATITUDE NXT System - LATITUDE NXT Patient Management System, LATITUDE Wave Communicator and LATITUDE NXT System Server (P910077/S176)Boston Scientific2020-04-01
Pacemaker Devices - INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S088)Boston Scientific2020-04-01
ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, and ACCOLADE MRI EL D (P150012/S091)Boston Scientific2020-03-17
ORIGEN MINI ICD VR, ORIGEN MINI ICD DR, INOGEN MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN MINI ICD VR, DYNAGEN MINI ICD DR (P960040/S449)Boston Scientific2020-03-17
ICD ORIGEN VR, ICD ORIGEN DR, ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, ICD AUTOGEN VR, ICD AUTOGEN (P960040/S448)Boston Scientific2020-03-05
PG ESSENTIO MRI SR, PG ESSENTIO MRI DR, PG PROPONENT MRI SR, PG PROPONENT MRI DR, PG ACCOLADE MRI SR, and PG ACCOLADE MR (P150012/S090)Boston Scientific2020-03-05
IntellaTip MiFi XP, IntellaNav MiFi XP and IntellaNav XP Temperature Ablation Catheters (P020025/S125)Boston Scientific2020-02-19
Blazer Prime XP and IntellaTip MiFi XP (P020025/S124)Boston Scientific2020-02-07
PG ESSENTION MRI SR/DR SL, PG ESSENTIO DR EL, PG ESSENTIO MRI DR EL, PG PROPONENT MRI SR/DR/ SL, PG PROPONENT MRI DR EL, (P150012/S089)Boston Scientific2020-01-28
ICE ORIGEN VR DF4, VR DF1/IS1, DR DF4/IS1, DR DF1/IS1, ICD INOGEN VR DF4, VR DF1/IS1, DR DF4/IS1, DR DF1/IS1, ICD DYNAGE (P960040/S447)Boston Scientific2020-01-28
IntellaNav MiFi XP amd IntellaNav XP (P020025/S123)Boston Scientific2020-01-27
Multiple Application Utility (MAU) and Data Management System (DM) LATITUDE Programming System )LPS) (P910077/S174)Boston Scientific2019-12-16
INGEVITY (P150012/S085)Boston Scientific2019-12-16
Ingevity + Lead - Active Fixation (P150012/S083)Boston Scientific2019-12-16
Origen Mini ICD VR, Origen Mini ICD DR, Inogen Mini ICD VR, Inogen Mini ICD DR, Dynagen Mini ICD VR, Dynagen Mini ICD DR (P960040/S445)Boston Scientific2019-12-04
Essentio MRI SR, Essentio MRI DR, Essentio MRI EL DR, Proponent, Accolade MRI SR, Accolade MRI DR and Accolade MRI EL DR (P150012/S087)Boston Scientific2019-12-04
Essentio MRI SR/DR SL, Essentio MRI DR EL, Proponent MRI SR/DR SL, Proponent MRI DR EL, Accolade MRI SR/DR SL and Accola (P150012/S086)Boston Scientific2019-11-27
LATITUDE Programming System (P910077/S175)Boston Scientific2019-11-26
VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM (P960040/S444)Boston Scientific2019-11-15
Blazer II XP Cardiac Ablation Catheter and Cable (P020025/S122)Boston Scientific2019-11-07
Implantable Cardioverter Defibrillator (ICD) (P960040/S443)Boston Scientific2019-10-29
MRI Pacemakers (P150012/S084)Boston Scientific2019-10-29
LATITUDE Programming System, Brady v1.06 with Heart Connect (P910077/S173)Boston Scientific2019-10-18
Pacemaker Devices: INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI and ACCOLADE MRI (P150012/S081)Boston Scientific2019-10-18
ICD Devices: TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT and PERC (P960040/S441)Boston Scientific2019-10-18
Essentio, Proponent, and Accolade MRI Pacemakers (P150012/S082)Boston Scientific2019-09-24
Origen, Inogen, Dynagen, Autogen, Vigilant, Resonate, Perciva, and Momentum Implantable Cardioverter Defibrillator (ICD) (P960040/S442)Boston Scientific2019-09-24
Autogen, Dynagen, Inogen, and Origen NG3 ICDs and Resonate, Momentum, Vigilant, and Perciva NG4 ICDs (P960040/S440)Boston Scientific2019-09-18
Essentio, Proponent, and Accolade MRI Pacemakers (P150012/S080)Boston Scientific2019-09-18
Maestro 4000 Controller Firmware (P020025/S121)Boston Scientific2019-08-23
Ingevity MRI Leads and Slit Suture Sleeve Accessory for Ingevity Leads (P150012/S078)Boston Scientific2019-07-31
Resonate, Momentum, Vigilant, Perciva, Autogen, Dynagen, Inogen, and Origen Implantable Cardioverter Defibrillators (ICD (P960040/S438)Boston Scientific2019-07-31
Reliance 4-Front Leads, Suture Sleeve Accessory for Reliance 4-Front Leads, Endotak Reliance 4-Site Leads and Endotak Re (P910073/S155)Boston Scientific2019-07-31
FineLine II Sterox Leads, Fineline II Sterox EZ Leads, and Suture Sleeve Accessories for FineLine II Leads (P960004/S090)Boston Scientific2019-07-31
LATITUDE Programming System (P910077/S172)Boston Scientific2019-07-08
LATITUDE Programming System (P910077/S169)Boston Scientific2019-07-08
INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI PROPONENT MRI and ACCOLADE MRI (P150012/S076)Boston Scientific2019-07-08
Pacemaker Devices: INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI (P150012/S073)Boston Scientific2019-07-08
TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT and PERCIVA ICD Devic (P960040/S437)Boston Scientific2019-07-08
ICD Devices: TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT and PERC (P960040/S434)Boston Scientific2019-07-08
NG3 and NG4 Implantable Cardioverter Defibrillators (ICDs) (P960040/S439)Boston Scientific2019-06-21
Accolade MRI Pacemakers (P150012/S079)Boston Scientific2019-06-21
RELIANCE 4-FRONT Steroid Eluting Leads (P910073/S156)Boston Scientific2019-06-19
Blazer II, Blazer II HTD, Blazer II XP, Blazer Prime HTD, Blazer Prime XP, IntellaTip MiFi XP, IntellaNav MiFi XP, Intel (P020025/S120)Boston Scientific2019-06-17
LATITUDE Wave Communicator (P910077/S171)Boston Scientific2019-06-10
Pacemaker Devices: INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S075)Boston Scientific2019-06-10
ICD Devices TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA (P960040/S436)Boston Scientific2019-06-10
Maestro™ Ablation Connection Box, IntellaNav™ OI (P020025/S118)Boston Scientific2019-05-29
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