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Boston Scientific

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

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RecordFirmDate
ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S068)Boston Scientific2019-05-23
Ingevity Leads (P150012/S077)Boston Scientific2019-05-23
Blazer II XP, Blazer Prime XP, IntellaTip MiFi XP, IntellaNav XP, IntellaNav MiFi XP (P020025/S119)Boston Scientific2019-05-03
Blazere II Ablation Catheters, Blazer II XP Ablation Catheters, Blazer Prime Ablation Catheters (P020025/S117)Boston Scientific2019-04-16
Accessory Kit (P940031/S078)Boston Scientific2019-04-08
Accessory Stylet TAPER .014 45CM, .014 52CM, .014 58CM, .016 45CM, .016 52CM, and .016 58CM, Accessory Stylet TAPER .013 (P960004/S089)Boston Scientific2019-04-08
Accessory Wrench (P930035/S030)Boston Scientific2019-04-08
Accessory Stylet STR 0.013 45CM, Accessory Stylet STR 0.013 52CM,Accessory Stylet STR 0.013 59CM, Accessory Stylet LTPR (P150012/S074)Boston Scientific2019-04-08
LV Lead Quadpole Connector IS4, Accessory Kit Lead Cap, Accessory Stylet TAPER FIX SOFT 64CM, 70CM, and 100CM, Accessory (P910073/S154)Boston Scientific2019-04-08
Accessory Hex Wrench (P840068/S054)Boston Scientific2019-04-08
ZOOM LATTITUDE Programmer System Accessory Kit, Adapter Power RF COmmunicator, Accessory Kit Lead Cap, Accessory Wand T (P910077/S170)Boston Scientific2019-04-08
Accessory Medical Adhesive, Accessory Mineral Oil, Accessory Vein Pick, Accessory Kit Lead Cap, Accessory Stylet TAPER 0 (P830060/S083)Boston Scientific2019-04-08
Accessory Kit Suture Sleeve Stabilizer and Accessory Terminal Pin Fixation Tool (P960006/S049)Boston Scientific2019-04-08
INGEVITY Distal Tip Laser Weld Process (P150012/S072)Boston Scientific2019-03-14
Implantable Cardioverter Defibrillator (P960040/S435)Boston Scientific2019-03-13
Fineline II Sterox, EZ. (P960004/S088)Boston Scientific2019-02-28
Reliance 4-Front, 4-Site IS-1 Defibrillation (P910073/S153)Boston Scientific2019-02-28
Ingevity MRI (P150012/S070)Boston Scientific2019-02-28
LATITUDE NXT Patient Management System, LATITUDE Wave Communicator, LATITUDE Consult Communicator and LATITUDE NXT Syste (P910077/S168)Boston Scientific2019-02-22
INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI and ACCOLADE MRI (Pacemaker Devices) (P150012/S067)Boston Scientific2019-02-22
TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, and PERCIVA (ICD Dev (P960040/S431)Boston Scientific2019-02-22
Accolade MRI Pacemakers (P150012/S071)Boston Scientific2019-02-19
NG3 Devices (P960040/S433)Boston Scientific2019-02-13
Maestro 4000 Controller (P020025/S113)Boston Scientific2019-01-28
Implantable Cardioverter Defibrillator (ICD) Origen, Inogen, Dynagen, Autogen, Momentum, Vigilant, Resonate and Perciva (P960040/S432)Boston Scientific2019-01-23
Fineline II Lead Family (P960004/S087)Boston Scientific2019-01-10
Ingevity Lead Family (passive fixation models) (P150012/S069)Boston Scientific2019-01-10
Reliance 4-Front Lead Family (passive fixation models) (P910073/S152)Boston Scientific2019-01-10
Programmer Recorder Monitor (PRM) for Implantable Pulse Generators, Model 3300 LATITUDE Programming System, Model 6395 I (P910077/S167)Boston Scientific2019-01-09
IntellaNav XP and MiFI XP (P020025/S115)Boston Scientific2019-01-09
Blazer II XP and Blazer Prime XP (P020025/S116)Boston Scientific2018-11-28
PUNCTUA, ENERGEN, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, MOMENTUM, VIGILANT, PERCIVA, RESONATE (P960040/S430)Boston Scientific2018-11-16
INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S066)Boston Scientific2018-11-16
ENDOTAK RELIANCE 4-SITE Leads (P910073/S151)Boston Scientific2018-11-13
INGEVITY Leads (P150012/S065)Boston Scientific2018-11-09
ICDs Autogen, Inogen, Dynagen, Origen, Resonate, Momentum, Vigilant, Perciva, Punctua, Energen, and Incepta (P960040/S429)Boston Scientific2018-10-10
Blazer II XP Cardiac Ablation Catheter and Cable (P020025/S114)Boston Scientific2018-09-19
Blazer II XP Cardiac Ablation Catheter and Cable (P020025/S111)Boston Scientific2018-09-07
Dynagen Mini ICD, Inogen Mini/EL ICD, Origen Mini/EL ICD, Dynagen EL ICD, Autogen EL ICD, Vigilant EL ICD, Perciva ICD, (P960040/S428)Boston Scientific2018-09-04
MANAGE HF Study (P960040/S426)Boston Scientific2018-08-21
FINELINE II Sterox Lead, FINELINE II Sterox EZ Lead abnd Suture Sleeve Accessory (for FINELINE II Leads) (P960004/S085)Boston Scientific2018-07-27
INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI Pacemakers, INGEVITY MRI Lead, Slit Sutu (P150012/S060)Boston Scientific2018-07-27
Ingevity, Ingevity MRI (P150012/S064)Boston Scientific2018-07-26
Fineline II (P960004/S086)Boston Scientific2018-07-26
Flextend (P960006/S048)Boston Scientific2018-07-26
Endotak Reliance, Reliance 4-Front (P910073/S150)Boston Scientific2018-07-26
ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI (P150012/S062)Boston Scientific2018-07-17
Blazer II XP Cardiac Ablation Catheter and Cable (P020025/S112)Boston Scientific2018-07-11
DYNAGEN MINI, INOGEN MINI, ORIGEN MINI and PERCIVA MINI (P960040/S427)Boston Scientific2018-07-11
INGEVITY MRI Passive Fixation Leads, INGEVITY non-MRI Passive Fixation Leads (P150012/S063)Boston Scientific2018-07-05
Implantable Cardioverter Defibrillator (ICD), Dynagen EL/Mini ICD, Inogen EL/Mini ICD, Origen EL ICD/Mini ICD, Autogen E (P960040/S425)Boston Scientific2018-06-01
Fineline ll Lead Family (P960004/S084)Boston Scientific2018-05-16
Endotak Reliance IS-1 Lead Family, Endotak Reliance IS4 Lead Family, Reliance 4-Front Lead Family (P910073/S149)Boston Scientific2018-05-16
Ingevity Lead Family (P150012/S059)Boston Scientific2018-05-16
Reliance 4- Front Lead Family and Suture Sleeve Accessory (P910073/S145)Boston Scientific2018-05-04
Ventak AV Acid Ventak Prizm DR/VR, Vitality, Cofient, and Teligen Automatic Implantable Cardioverter Defibrillator Syste (P960040/S423)Boston Scientific2018-04-25
Imageready MR Conditional Pacing System and Ingevity Pace/Sense Lead (P150012/S058)Boston Scientific2018-04-25
Ventak(R) PRX (TM) Model 1700,1705 Pulse Generator (P910077/S166)Boston Scientific2018-04-25
Ventak and Automatic Implantable Cardioverter Defibrillator (AICD) Systems (P830060/S082)Boston Scientific2018-04-25
Thinline Endocardial Pacing Leads (P960004/S083)Boston Scientific2018-04-25
Ventak(R) P2 System (P930035/S029)Boston Scientific2018-04-25
Endotak Lead System (P910073/S148)Boston Scientific2018-04-25
Sweet Tip(R) RX Steroid Eluting Lead (P960006/S047)Boston Scientific2018-04-25
Lead Cap Kit (model 7007) (P910073/S146)Boston Scientific2018-04-19
Accolade MRI, Essentio MRI, Proponent MRI (P150012/S055)Boston Scientific2018-04-11
NG2.5 (Dynagen Mini/Inogen Mini/ Origen Mini), Pervica ICD Pulse Generator (P960040/S424)Boston Scientific2018-04-10
INGEVITY MRI Active Fixation Lead Models (P150012/S056)Boston Scientific2018-04-05
Latitude Programming System (P910077/S165)Boston Scientific2018-03-26
Teligen, Energen, Punctua, Incepta, Origen, Inogen, Dynagen, Autogen, Resonate, Momentum, Vigilant, Perciva (P960040/S418)Boston Scientific2018-03-26
Ingenio MRI, Vitalio MRI, Formio MRI, Essentio MRI, Proponent MRI, Accolade MRI (P150012/S052)Boston Scientific2018-03-26
RESONATE, MOMENTUM, VIGILANT, and PERCIVA NG4 ICDs (P960040/S421)Boston Scientific2018-03-22
Implantable Cardioverter Defibrillator (ICD): PUNCTUA, ENERGEN, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, MOMENTUM, VIG (P960040/S422)Boston Scientific2018-03-12
Accolade MRI Pacemakers: ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI (P150012/S054)Boston Scientific2018-03-12
NG3 Implantable Cardioverter Defibrillators - Origen, Inogen, Dynagen, Autogen / NG4 - Momentum, Vigilant, Resonate, Per (P960040/S420)Boston Scientific2018-02-21
Blazer II XP Cardiac Ablation Catheter and Cable (P020025/S110)Boston Scientific2018-02-16
FINELINE II Lead Family (P960004/S082)Boston Scientific2018-02-08
ESSENTIO; PROPONENT; ACCOLADE MRI (P150012/S053)Boston Scientific2018-02-08
DYNAGEN EL/MINI; INOGEN EL/MINI; ORIGEN EL/MINI; AUTOGEN EL; VIGILIANT EL; PERCIVA; RESONATE EL/HF; PERCIVA HF; MOMENTUM (P960040/S419)Boston Scientific2018-02-08
NG3 Family of ICDs (Autogen, Dynagen, Inogen and Origen) NG4 Family of ICDs (Resonate, Vigilant and Perciva) (P960040/S414)Boston Scientific2018-02-02
Ventak PRx and Ventak Mini AICDs (P910077/S164)Boston Scientific2018-02-02
Essentio MRI, Proponent MRI, Accolade MRI Pacemakers (P150012/S051)Boston Scientific2018-02-02
Origen, Inogen, Dynagen, Autogen, Momentum, Vigilant, Resonate, Perciva,Punctua, Energen, Incepta ICD (P960040/S416)Boston Scientific2018-01-19
Implantable Cardioverter Defibrillator / Momentur, Vigilant, Resonate, Perciva (P960040/S417)Boston Scientific2018-01-15
DYNAGEN, INOGEN, ORIGEN, AUTOGEN EL ICD; DYNAGEN MINI, INOGEN MINI, ORIGEN MINI ICD; INCEPTA, ENERGEN, PUNCTUA ICD; MOME (P960040/S415)Boston Scientific2018-01-10
Imageready MR Conditional Pacing System and Ingevity Pace/Sense Lead (P150012/S044)Boston Scientific2018-01-07
Latitude Programming System (P910077/S163)Boston Scientific2018-01-07
Ventak AV Aicd Ventak Prizm DR/VR, Vitality, Cofient and Teligen Automatic Implantable Cardiovetr Defibrillator System (P960040/S408)Boston Scientific2018-01-07
ENDOTAK RELIANCE S /GS /G (P910073/S147)Boston Scientific2018-01-05
Accolade MRI, Essentio MRI, Formio MRI, Ingenio MRI, Proponent MRI, Vitalio MRI (P150012/S050)Boston Scientific2017-12-19
Autogen, Dynagen, Energen, Incepta, Inogen, Momentum, Origen, Perciva, Punctua, Resonate, Vigiliant, Vitality ICDs (P960040/S412)Boston Scientific2017-12-19
Latitude NXT Patient Management System, Wave Communicator, G2 Communicator, Consult Communicator, NXT System Server Soft (P910077/S162)Boston Scientific2017-12-13
Teligen, Energen, Punctua, Incepta, Origen, Inogen, Dynagen, Autogen, Resonate, Momentum, Vigilant, Pervica (P960040/S406)Boston Scientific2017-12-13
IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD (P150012/S043)Boston Scientific2017-12-13
NG3 Implantable Cardiac Defibrillators (ICDs): AUTOGEN, DYNAGEN, INOGEN and ORIGEN; NG4 ICDs: MOMENTUM, VIGILANT, PERCIV (P960040/S410)Boston Scientific2017-12-11
Accolade MRI Pacemakers: ESSENTIO MRI, PROPONENT MRI and ACCOLADE MRI (P150012/S046)Boston Scientific2017-12-11
ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI, MRI Pacemakers (P150012/S048)Boston Scientific2017-12-06
ESSENTIO MRI / PROPONENT MRI /ACCOLADE MRI / Accolade MRI Pacemakers (P150012/S049)Boston Scientific2017-12-06
ORIGEN, INOGEN, DYNAGEN, AUTOGEN, MOMENTUM, VIGILANT, RESONATE, PERCIVA, PUNCTUA, ENERGEN, INCEPTA , Inplantable Cardiov (P960040/S411)Boston Scientific2017-12-06
ORIGEN / INOGEN / DYNAGEN /AUTOGEN /MOMENTUM /VIGILANT/ PERCIVA / RESONATE/ Implantable Cardioverter Defibrillator (ICD) (P960040/S413)Boston Scientific2017-12-06
Accolade MRI, Essentio MRI, Proponent MRI (Accolade MRI) (P150012/S045)Boston Scientific2017-12-01
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