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Boston Scientific

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

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RecordFirmDate
Blazer II XP Cardiac Ablation Catheter and Cable (P020025/S109)Boston Scientific2017-12-01
Plasma Treatment System (P910073/S144)Boston Scientific2017-12-01
Autogen, Dynagen, Inogen, Origen (NG3 ICDs), Momentum, Vigilant, Perciva, Resonate (NG4 ICDs) (P960040/S409)Boston Scientific2017-12-01
Active Fixation INGEVITY Leads (P150012/S047)Boston Scientific2017-11-28
SMART-MSP (P960040/S405)Boston Scientific2017-11-17
Blazer II XP Cardiac RF Ablation System(also branded as as Blazer (II XP, PRime XP); IntellaTip MiFi XP; IntellaNav XP a (P020025/S108)Boston Scientific2017-11-01
Autogen, Dynagen, Inogen,Origen / NG3 Implantable Cardiac Defibrillators / Momentur, Vigilant, Perciva, Resonate / NG4 I (P960040/S407)Boston Scientific2017-10-26
Essentio MRI, Proponent MRI, Accolade MRI - Accolade MRI Pacemakers (P150012/S041)Boston Scientific2017-10-26
Accolade MRI Pacemakers: ESSENTIO MRI, PROPNENT MRI, ACCOLADE MRI (P150012/S042)Boston Scientific2017-10-20
Essentio MRI / Proponent MRI / Accolade MRI / Accp;ade MRI Pacemakers (P150012/S040)Boston Scientific2017-10-18
Blazer II XP/ Blazer Prime XP / Intella Tip MiFi XP / IntellaNav, IntellaNav MiFi XP (P020025/S107)Boston Scientific2017-10-11
ICDs: PUNCTUA, ENERGEN, INCEPTA (P960040/S404)Boston Scientific2017-10-11
INGEVITY Active-Fixation Non-MRI / Active-Fixation MRI (P150012/S038)Boston Scientific2017-10-05
ORIGEN, INOGEN, DYNAGEN, AUTOGEN, MOMENTUM, VIGILANT, PERCIVA, RESONATE; Implantable Cardioverter Defibrillator(ICD) (P960040/S402)Boston Scientific2017-09-28
Blazer II XP, Blazer Prime XP, IntellaTip MiFi XP, IntellaNav XP, IntellaNav MiFi XP (P020025/S106)Boston Scientific2017-09-26
ICDs: Origen, Inogen, Dynagen, Momentum EL ICD, Autogen, Vigiliant EL ICD, Perciva ICD, Resonate EL ICD, Perciva HF ICD, (P960040/S403)Boston Scientific2017-09-25
Pacemakers: Ingenio MRI, Vitalio MRI, Formio MRI, Essentio MRI, Proponent MRI, and Accolade MRI (P150012/S037)Boston Scientific2017-09-25
ESSENTIO MRI / PROPONENT MRI / ACCOLADE MRI (P150012/S034)Boston Scientific2017-09-21
ENDOTAK RELIANCE™, (Defibrillation Leads) (P910073/S142)Boston Scientific2017-09-20
RESONATE, VIGILANT, PERCIVA NG4 ICDs AUTOGEN, DYNAGEN, INOGEN, ORIGEN NG3 ICDs (P960040/S395)Boston Scientific2017-09-20
INGEVITY™ MRI Leads, Slit Suture Sleeve Accessory for INGEVITY Leads (Pacing Leads and Accessories) (P150012/S032)Boston Scientific2017-09-20
Multi-Application Utility Model, (Non-Implantable Accessories) (P910077/S161)Boston Scientific2017-09-20
FINELINE™ II Sterox Leads, Suture Sleeve Accessory for FINELINE II Leads, (Pacing Leads and Accessories) (P960004/S081)Boston Scientific2017-09-20
Torque Wrench (P960040/S398)Boston Scientific2017-09-11
INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, ACCOLADE MRI, PROPONENT MRI (P150012/S039)Boston Scientific2017-09-11
LATITUDE™ Programming System (P910077/S159)Boston Scientific2017-09-11
Torque Wrench (P150012/S033)Boston Scientific2017-09-11
Teligen, Energen, Puntua, Incepta, Origen, Inogen, Dynagen, Autogen (P960040/S391)Boston Scientific2017-09-11
Blazer II XP Cardiac RF Ablation System (P020025/S105)Boston Scientific2017-08-31
Accolade MRI Pacemakers, Essentio MRI, Proponent MRI, Accolade MRI (P150012/S035)Boston Scientific2017-08-30
NG3 Implantable Cardiac Defibrillators, Autogen, Dynagen, Inogen, Origen ICD's; NG4 ICDs- Momentum, Vigilant, Perciva,Re (P960040/S399)Boston Scientific2017-08-30
ICDS: ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE HF ICD, RESONATE EL ICD, MOMENTUM EL ICD, VIGILIANT EL ICD, PERCIVA HF (P960040/S401)Boston Scientific2017-08-30
Pacemakers: ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S036)Boston Scientific2017-08-30
Blazer II XP Cardiac Ablation Catheter and Cable (P020025/S104)Boston Scientific2017-08-17
NG3 Implantable Cardiac Defibrillators, Autogen, Dynagen, Inogen, Origen ICD's; NG4 ICDs- Momentum, Vigilant, Perciva,Re (P960040/S400)Boston Scientific2017-08-07
LATITUDE NXT Release Patient Management System (P910077/S160)Boston Scientific2017-08-07
TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, PERCIVA, RESONATE, MOMENTUM, VIGILANT (P960040/S393)Boston Scientific2017-08-07
INGEVITY MRI models: 7731, 7732, 7735, 7736, 7740, 7741, 7742 (P150012/S031)Boston Scientific2017-07-27
Autogen, Dynagen, Inogen, Origen NG3 ICDs; Resonate, Vigilant, Perciva NG4 ICDs (P960040/S396)Boston Scientific2017-07-25
Blazer II ™ XP Cardiac Ablation Catheter and Cable (P020025/S103)Boston Scientific2017-07-24
Blazer (II XP, Prime XP); IntellaTip MiFi XP; IntellaNav XP and IntellaNav MiFi XP (P020025/S101)Boston Scientific2017-07-24
MULTIPLE APPLICATION UTILITY MODEL 2909 (FROM V9.03 TO V9.04) (P910077/S155)Boston Scientific2017-07-06
FINELINE II Lead (P960040/S397)Boston Scientific2017-06-30
ENDOTAK RELIANCE IS-1 LEAD (P910073/S143)Boston Scientific2017-06-30
IntellaNav XP and IntellaNav MiFi XP Temperature Ablation Catheters (P020025/S102)Boston Scientific2017-06-27
RF Filter Module (P020025/S095)Boston Scientific2017-06-23
Implantable Cardioverter Defibrillator (ICD) - Origen: D000, D001, D002, D003, D050, D051, D052, D053 - Inogen: D010, D0 (P960040/S394)Boston Scientific2017-06-21
Implantable Cardioverter Defibrillator (ICD) ORIGEN, INOGEN, DYNAGEN, AUTOGEN, PUNCTUA, ENERGEN, INCEPTA, MOMENTUM, VIGI (P960040/S392)Boston Scientific2017-06-06
Intella Tip MiFi XP cardiac ablation catheters (P020025/S098)Boston Scientific2017-06-01
Fineline II Sterox and Sterox EZ Lead (P960004/S080)Boston Scientific2017-05-23
Ingevity Lead (P150012/S030)Boston Scientific2017-05-23
Ingevity Lead Manufacturing Changes (P150012/S029)Boston Scientific2017-05-19
Implantable Cardioverter Defibrilllator/ Dynagen, Inogen, Origen and Autogen ICD's. (P960040/S390)Boston Scientific2017-05-18
Blazer II XP Cardiac Ablation Catheter and Cable (P020025/S100)Boston Scientific2017-05-12
IntellaNav XP, Nav MiFi XP (P020025/S096)Boston Scientific2017-05-08
Maestro 4000 Cardiac Ablation System (Controller, Remote and Pods) (P020025/S099)Boston Scientific2017-05-04
NG4 Family of Pulse Generators ICDS. (P960040/S385)Boston Scientific2017-05-02
Essentio, Proponent, Accolade MRI. (P150012/S028)Boston Scientific2017-05-01
LATITUDE™ NXT Patient Management System/ LATITUDE NXT G2 Communicator (P910077/S158)Boston Scientific2017-04-21
Teligen, Energen, Punctua, Incepta, Origen, Inogen, Dynagen, Autogen ICD Devices (P960040/S389)Boston Scientific2017-04-21
ACUITY X4 Lead (P910073/S141)Boston Scientific2017-04-19
FINELINE II Sterox and Sterox EZ Lead (P960004/S079)Boston Scientific2017-04-19
INGEVITY Lead (P150012/S027)Boston Scientific2017-04-19
LATITUDE NXT Release 5.0 (P910077/S156)Boston Scientific2017-04-17
TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA ICD's (P960040/S384)Boston Scientific2017-04-17
ESSENTIO, PROPONENT, ACCOLADE, INGEVITY MRI'S & SLIT SUTURE SLEEVE ACCESSORY (FOR INGEVITY MRI LEADS) (P150012/S021)Boston Scientific2017-04-11
FINELINE II STEROX & FINELINE II STEROX EZ, SUTURE SLEEVE ACCESSORY(FOR FINELINE II LEADS) (P960004/S078)Boston Scientific2017-04-11
ESSENTIO MRI Models: L110, L111, L131; PROPONENT MRI Models: L210, L211, L231; ACCOLADE MRI Models: L310, L311, L331 (P150012/S026)Boston Scientific2017-03-29
Blazer II XP Cardiac Ablation Catheter and Cable (P020025/S097)Boston Scientific2017-03-24
TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN (P960040/S386)Boston Scientific2017-02-16
LATITUDE™ NXT Patient Management System, LATITUDE Wave Communicator (P910077/S157)Boston Scientific2017-02-16
DYNAGEN, INOGEN, ORIGEN, AUTOGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) (P960040/S388)Boston Scientific2017-02-14
INTELLANAV XP TEMPERATURE ABLATION CATHETERS (P020025/S094)Boston Scientific2017-02-09
INGEVITY LEADS (P150012/S025)Boston Scientific2017-01-18
Incepta, Energen, Punctua, Autogen, Dynagen, Inogen, Origen, Resonate, Vigilant, Momentum, and Perciva ICDs (P960040/S387)Boston Scientific2017-01-11
Accolade MRI, Proponent MRI, and Essentio MRI (P150012/S024)Boston Scientific2017-01-11
INGEVITY NON-MRI LEAD & INGEVITY MRI LEAD (P150012/S023)Boston Scientific2017-01-10
ENDOTAK RELIANCE SYSTEM (P910073/S140)Boston Scientific2017-01-10
IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD (P150012/S022)Boston Scientific2017-01-08
Blazer II XP; Blazer Prime XP (P020025/S093)Boston Scientific2016-12-23
IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM, NG2.5, DYNAGEN, INOGEN, ORIGEN MINI ICD's (P960040/S383)Boston Scientific2016-12-22
INTELLANAV MIFI XP; INTELLATIP MIFI XP (P020025/S091)Boston Scientific2016-12-13
ESSENTIO MRI Models L110, L111, L131; (P150012/S020)Boston Scientific2016-12-12
LATITUDE NXT System (P910077/S154)Boston Scientific2016-12-12
AUTOGEN EL ICD MODELS D160, D161, D162, D163. (P960040/S374)Boston Scientific2016-12-12
INGEVITY (P150012/S019)Boston Scientific2016-12-07
IntellaNav XP, IntellaNav MiFi XP Ablation Catheters (P020025/S092)Boston Scientific2016-12-06
ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S018)Boston Scientific2016-11-30
ESSENTIO, PROPONENT, ACCOLADE MRI PACEMAKERS (P150012/S017)Boston Scientific2016-11-03
IMPLANTABLE CARDIOVETER DEFIBRILLATOR, DYNAGEN, INOGEN, ORIGEN, PUNCTUA, ENERGEN, INCEPTA MINI, EL, ICD (P960040/S382)Boston Scientific2016-10-13
ESSENTIO, PROPONENT, ACCOLADE PACEMAKER (P150012/S016)Boston Scientific2016-10-12
ORIGEN EL, INOGEN EL, DYNAGEN EL NG3 ICD;ORIGEN MINI, INOGEN MINI, DYNAGEN MINI NG2.5 ICD; INCEPTA, ENERGEN, PUNCTUA PRO (P960040/S381)Boston Scientific2016-10-12
Essentio, Proponent and Accolade MRI Pacemakers (P150012/S013)Boston Scientific2016-10-04
ORIGEN; INOGEN; DYNAGEN; PUNCTUA; ENERGEN; INCEPTA ICDS (P960040/S380)Boston Scientific2016-09-29
ESSENTIO MRI; PROPONENT MRI; ACCOLADE MRI Pacemakers (P150012/S015)Boston Scientific2016-09-29
ENDOTAK RELIANCE 4-SITE, Defibrillation Lead Family ,Active Fixation Models (New): 0272, 0273. Passive Fixation Models ( (P910073/S138)Boston Scientific2016-09-29
Ingenio 2 Pacemakers, ESSENTIO, PROPONENT, ACCOLADE MRI MODELS (P150012/S014)Boston Scientific2016-09-13
NG3 Implantable Cardioverter Defibrillator (ICD), ORIGEN, INOGEN, DYNAGEN EL ICD'S; NG2 Implantable Cardioverter Defibri (P960040/S379)Boston Scientific2016-09-13
ENDOTAK RELIANCE G/SG DEFIBRILLATION LEADS AND G/SG WITH 4-SITE CONNECTOR DEFIBRILLATION LEADS (P910073/S139)Boston Scientific2016-08-22
Dynagen EL & Mini, Inogen EL & Mini, Origen EL & MIni IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM (P960040/S376)Boston Scientific2016-08-19
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